PI Country
Participating Country

ECRIN-Supported Trials

By combining the expertise, resources and capacities of national networks, ECRIN promotes synergistic, multinational clinical trials. Summaries of current and past trials in the ECRIN portfolio are shown below. Use the search bar to find current trials.

A phase IIb, prospective, multicentre, double-blind, triplearm, randomized versus placebo trial, to assess the efficacy of a single injection of either 2 or 10 x 106 autologous adipose derived mesenchymal stromal cells (ASC) in the treatment of mild to moderate osteoarthritis (OA) of the knee, active and unresponsive to conservative therapy for at least 12 months.

Disease
Osteoarthritis
Study phase
IIb
ECRIN support role
Advice and information
Monitoring
Funding application support
Local pharmacovigilance
Central project management
Local project management
Regulatory and ethical submission
Data management
Study/trial status
Recruitment/follow-up
Expected patient number
153 patients
Sponsor
Centre Hospitalier Universitaire Montpellier
Sponsor type
Academic
Principal investigator (PI)
Christian Jorgensen
Current participating countries
France
Germany
Ireland
Italy
Netherlands
United Kingdom
Trial identifier(s)
EudraCT
2015-002125-19

This study aims to validate the mechanism-based taxonomies of Alzheimer's Disease and Parkinson's Disease generated by the AETIONOMY Innovative Medicines Initiative (IMI) project for two biomarkers for Alzheimer's Disease and two biomarkers for Parkinson's Disease.

Disease
Alzheimer's disease, Parkinson's disease
Study phase
Other
ECRIN support role
Monitoring
Regulatory and ethical submission
Study/trial status
Recruitment/follow-up
Actual trial start date
Expected patient number
655 patients
Sponsor
Institut National de la Sante et de la Recherche Medicale (INSERM)
Sponsor type
Academic
Principal investigator (PI)
Jean-Christophe Corvol
Current participating countries
France
Germany
Spain
Sweden

Prospective, randomized, placebo-controlled, multi-centric international phase IIb clinical trial. The target population consists of patients with cardiac structural remodelling with or without symptoms of heart failure (maximum NYHA II). The objective is to evaluate mirabegron (a new β3-specific agonist) over 12 months as add-on to standard treatment compared to standard treatment alone. Endpoints focus on cardiac remodelling: Quantitative indices of hypertrophy and left ventricle (LV) function, in addition exercise tolerance is investigated.

Disease
Cardiac disease
Study phase
IIb
ECRIN support role
Advice and information
Monitoring
Funding application support
Local pharmacovigilance
Local project management
Regulatory and ethical submission
Data management
Study/trial status
Start-up phase
Actual trial start date
Expected patient number
296 patients
Sponsor
Université Catholique de Louvain (UCL) Place de l’Université 1 1348 Louvain la Neuve Belgium Authorised representative of the sponsor.
Sponsor type
Academic
Principal investigator (PI)
Jean-Luc Balligand
Current participating countries
Belgium
France
Germany
Greece
Italy
Poland
Portugal
United Kingdom
Main publications
Belge C, Hammond J, Dubois-Deruy E, Manoury B, Hamelet J, Beauloye C, Markl A, Pouleur AC, Bertrand L, Esfahani H, Jnaoui K, Götz KR, Nikolaev VO, Vanderper A, Herijgers P, Lobysheva I, Iaccarino G, Hilfiker-Kleiner D, Tavernier G, Langin D, Dessy C, Balligand JL. Enhanced expression of β3-adrenoceptors in cardiac myocytes attenuates neurohormone-induced hypertrophic remodeling through nitric oxide synthase. Circulation. 2014 Jan 28,129(4):451-62. doi: 10.1161/CIRCULATIONAHA.113.004940. Epub 2013 Nov 4. Balligand JL. beta(3)-Adrenoceptor stimulation on top of beta(1)-adrenoceptor blockade Stop or Encore?. J Am Coll Cardiol. 2009 Apr 28,53(17):1539-42. doi: 10.1016/j.jacc.2009.01.048. Dessy C, Balligand JL. Beta3-adrenergic receptors in cardiac and vascular tissues emerging concepts and therapeutic perspectives. Adv Pharmacol. 2010,59:135-63. doi: 10.1016/S1054-3589(10)59005-7. Review.
Trial identifier(s)
NCT
NCT02599480
ISRCTN
ISRCTN65055502

Cervical cancer is the second most common cause of cancer death in women worldwide. There is a need for improvement in diagnosis and treatment. The aim of the BIO-RAIDs study is to identify predictive biomarkers of standard treatment response using an integrative approach combining exome sequencing, proteomics and tumor micro environment analyses.

Disease
Cervical cancer
Study phase
Other
ECRIN support role
Monitoring
Regulatory and ethical submission
Study/trial status
Recruitment/follow-up
Actual trial start date
Expected patient number
700 patients
Sponsor
Institut Curie, Paris
Sponsor type
Academic
Principal investigator (PI)
Anne de La Rochefordiere
Current participating countries
Belgium
France
Germany
Netherlands
Romania
Serbia
Trial identifier(s)
NCT
NCT02428842

The purpose of this study is to investigate the efficacy of an engineered cartilage transplant (N-TEC) in comparison to a cell-activated matrix (N-CAM) for the treatment of articular cartilage lesions in the knee. The main innovations in this trial are the use of nasal chondrocytes and the implantation of a tissue in contrast to cells seeded on a matrix. The goals of the trial are to: (i) evaluate whether implantation of a more mature graft (tissue therapy) is beneficial for the quality and durability of the repair tissue and the clinical outcome, (ii) determine the potential of the mature graft to integrate with the adjacent cartilage and form hyaline repair tissue and (iii) assess the efficacy of each treatment in correlation to the characteristics of the defect (e.g. acute versus chronic setting).

Disease
Articular cartilage lesions in the knee
Study phase
II
ECRIN support role
Monitoring
Regulatory and ethical submission
Work package leader
Study/trial status
Start-up phase
Actual trial start date
Expected patient number
108 patients
Sponsor
University Hospital of Basel (USB)
Sponsor type
Academic
Principal investigator (PI)
Marcel Jakob, Marcus Mumme
Current participating countries
Croatia
Germany
Italy
Switzerland
Trial identifier(s)
NCT
NCT02673905

This is a pragmatic randomised controlled trial (PRCT) evaluating the superiority of CT over ICA concerning effectiveness in stable chest pain patients with intermediate pretest probability of coronary artery disease.

Disease
Coronary artery disease
ECRIN support role
Monitoring
Study/trial status
Recruitment/follow-up
Actual trial start date
Expected patient number
3546 patients
Sponsor
Charite/Universitätsmedizin Berlin, Germany
Sponsor type
Academic
Principal investigator (PI)
Marc Dewey
Current participating countries
Austria
Belgium
Czech Republic
Denmark
Finland
France
Germany
Hungary
Ireland
Italy
Latvia
Lithuania
Netherlands
Portugal
Romania
Serbia
Spain
United Kingdom
Trial identifier(s)
NCT
NCT02400229

The purpose of this trial is to make a comparison between the use of antiseptic silver alloy-coated silicone urinary catheters and the use of conventional silicone urinary catheters in spinal cord injured patients to prevent urinary infections.

Disease
Spinal cord injuries
Study phase
IV
ECRIN support role
Monitoring
Local pharmacovigilance
Local project management
Study/trial status
Recruitment/follow-up
Actual trial start date
Expected patient number
742 patients
Sponsor
Fundacio Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor type
Academic
Principal investigator (PI)
David Rigau
Current participating countries
Italy
Netherlands
Portugal
Spain
Turkey
Main publications
Bonfill X, Rigau D, Jáuregui-Abrisqueta ML, Barrera Chacón JM, de la Barrera SS, Alemán-Sánchez CM, Bea-Muñoz M, Moraleda Pérez S, Borau Duran A, Espinosa Quirós JR, Ledesma Romano L, Fuertes ME, Araya I, Martínez-Zapata MJ. A randomized controlled trial to assess the efficacy and cost-effectiveness of urinary catheters with silver alloy coating in spinal cord injured patients: trial protocol. BMC Urol. 2013 Jul 30,13:38. doi: 10.1186/1471-2490-13-38.
Trial identifier(s)
NCT
NCT01803919

The purpose of this study is to determine if systemic cooling to a target temperature of 34 to 35°C, started within six hours of symptom onset and maintained for 24 hours, improves functional outcome at three months in patients with acute ischaemic stroke.

Disease
Acute ischaemic stroke
Study phase
III
ECRIN support role
Monitoring
Study/trial status
Recruitment/follow-up
Expected patient number
800 patients
Sponsor
University of Erlangen-Nurnberg Medical School
Sponsor type
Academic
Principal investigator (PI)
Stefan Schwab
Current participating countries
Belgium
Bulgaria
Croatia
Czech Republic
Denmark
France
Germany
Greece
Hungary
Ireland
Italy
Netherlands
Norway
Poland
Romania
Spain
Sweden
Turkey
United Kingdom
Main publications
EuroHYP-1: European multicenter, randomized, phase III clinical trial of therapeutic hypothermia plus best medical treatment vs. best medical treatment alone for acute ischemic stroke. van der Worp HB1, Macleod MR, Bath PM, Demotes J, Durand-Zaleski I, Gebhardt B, Gluud C, Kollmar R, Krieger DW, Lees KR, Molina C, Montaner J, Roine RO, Petersson J, Staykov D, Szabo I, Wardlaw JM, Schwab S, EuroHYP-1 investigators.
Trial identifier(s)
NCT
NCT01833312

This study evaluates the effect of iron chelation as a therapeutic strategy to slow the progression of Parkinson's disease. Half of participants will receive the deferiprone to 15 mg / kg twice daily morning and evening (30mg / kg per day), while the other half will receive a placebo. The treatment lasts nine months.

Disease
Parkinson's disease
Study phase
II
ECRIN support role
Advice and information
Monitoring
Funding application support
Local pharmacovigilance
Regulatory and ethical submission
Study/trial status
Recruitment/follow-up
Actual trial start date
Expected patient number
338 patients
Sponsor
University Hospital Lille (CHRUL) 
Sponsor type
Academic
Principal investigator (PI)
David Devos
Current participating countries
Austria
Czech Republic
France
Germany
Netherlands
Portugal
Spain
United Kingdom
Trial identifier(s)
NCT
NCT02655315

The main goal of HIVACAR is to change the current paradigm of HIV treatment by obtaining a functional cure for HIV (i.e., control of viral load to levels below the threshold of 50 copies/ml and maintenance of high CD4+ T-cell count after discontinuation of antiretroviral therapy) thanks to effectively targeting residual virus replication and viral reservoirs. In order to do so, the planned novel strategy is to successfully combine immune-based therapies, including therapeutic vaccines and broadly neutralizing antibodies with latency reversing agents, in a proof-of-concept phase IIa clinical trial.

The HIVACAR project will lead to a reduction of the actual costs related to HIV treatment and management and of the social public health as well as an improvement in the patients’ quality of life. HIVACAR has been conceived under the framework of responsible research and innovation, so patients and other stakeholders will have a key role from the inception of the project until obtaining the results. Patients will be perfectly aware of how this therapy has been conceived and the real impact and change in their actual quality of life, as well as how the clinical trial has been designed and the consequences of participating in it. In addition, patients (and the general population) will tailor the project and its results dissemination and communication. This patient engagement will not be limited to the clinical trial but also to the rest of the activities of the project, so patients and the general society will be aware of how the research is developed and can include the patients’ point of view in the research activities. In addition, the socio-economic and psycho-social impact of the new treatment will be also analysed so overwhelming data on the benefits and impact of the new treatment will be obtained and shown to all stakeholders.

Disease
HIV
Study phase
II
ECRIN support role
Advice and information
Monitoring
Central pharmacovigilance
Funding application support
Local pharmacovigilance
Central project management
Local project management
Regulatory and ethical submission
IMP support
Biological sample support
Work package leader
Data management
Trial management
Study/trial status
Start-up phase
Expected patient number
56 patients
Sponsor
Institut de Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)
Sponsor type
Academic
Principal investigator (PI)
Dr Felipe García, Hospital Clínic Barcelona
Current participating countries
Belgium
Denmark
France
Spain
Trial identifier(s)
EudraCT
2017-000566-30

The purpose of this study is to prolong the time to reinfection with Pseudomonas aeruginosa after successfully treated acute or intermittent infection.

Disease
Cystic fibrosis
Study phase
III
ECRIN support role
Advice and information
Monitoring
Local pharmacovigilance
Regulatory and ethical submission
Study/trial status
Recruitment/follow-up
Expected patient number
180 patients
Sponsor
Mukoviszidose Institut gGmbH
Sponsor type
Academic
Principal investigator (PI)
Antje Schuster
Current participating countries
Austria
Belgium
France
Germany
Hungary
Italy
Poland
Spain
Sweden
Trial identifier(s)
NCT
NCT01455675
EudraCT
2011-000801-39

The objective of the LIVERHOPE project is to evaluate a novel therapeutic strategy for patients with cirrhosis based on a combination of rifaximin and simvastatin, targeting the main pathophysiological mechanisms of disease progression , namely the impairment in the gut-liver axis and the persistent hepatic and systemic inflammatory response. This dual therapeutic approach is supported by preclinical data showing excellent and very promising results.

LIVERHOPE will include two randomized double-blind trials (LIVERHOPE SAFETY and LIVERSHOPE EFFICACY) to investigate safety, tolerability and efficacy of combination of simvastatin plus rifaximin in patients with decompensated cirrhosis in six EU countries (285 patients will be enrolled in two trials in Germany, France, Italy, Spain, The Netherlands, and the United Kingdom). The expected impact is to halt progression to acute-on-chronic liver failure, the main cause of death, to decrease complications of the disease, to reduce hospital re-admissions, to improve cost-effectiveness of therapy.

Disease
Liver cirrhosis
Study phase
II
ECRIN support role
Funding application support
Data management
Trial management
Study/trial status
Start-up phase
Expected patient number
45 patients
Sponsor
IDIBAPS
Sponsor type
Academic
Principal investigator (PI)
Pere Ginès
Current participating countries
France
Germany
Italy
Netherlands
Spain
United Kingdom
Trial identifier(s)
EudraCT
2016-004499-23

The major objective is to develop novel clinical endpoints for clinical trials with a regulatory and patient access intention in patients with intermediate age-related macular degeneration (iAMD). Additional objectives are to characterise visual impairment in iAMD and its progression, as well as identify risk factors for progression to late stage AMD.

Study/trial status
Start-up phase
Sponsor type
Academic

As the number of older people in Europe grows, increasing healthy life years is a priority. Cognitive decline, dementia (e.g. Alzheimer’s disease, AD), sleep disturbances and depression, all related to psychological distress and anxiety, are significant drivers of reduced quality of life in older adults. This study is part of a project that builds on evidence that lifestyle factors and meditation practice have the potential to downregulate these adverse factors and positively impact mental and neurological conditions including AD. In particular, the study aims to assess the short-term effects of an eight-week meditation intervention (versus cognitive training) in patients with subjective cognitive decline at risk for AD on behavioural measures including anxiety and wellbeing.

Disease
Alzheimer’s disease, Other
Study phase
III
ECRIN support role
Monitoring
Funding application support
Local pharmacovigilance
Regulatory and ethical submission
Study/trial status
Recruitment/follow-up
Expected patient number
160 patients
Sponsor
Inserm
Sponsor type
Academic
Principal investigator (PI)
Nathalie Marchant
Current participating countries
France
Germany
Spain
United Kingdom

Cancer cachexia is a multi-factorial syndrome defined by an ongoing loss of skeletal muscle mass (with or without loss of fat mass) that cannot be fully reversed by conventional nutritional support and leads to progressive functional impairment. There is an urgency for improving management, but there is no consensus on the optimal treatment for cancer cachexia. Several single therapies for cancer cachexia have been examined in clinical trials, with disappointing overall results. As multiple factors are responsible for the development of cachexia, it has been argued that optimal cachexia interventions should target all components: multimodal therapy for a multimodal problem. The overall aim of this study is to early prevent the development of cachexia rather than treatment late in the disease trajectory. From a patient perspective a short term effect will be to improve physical and psychological function, to reduce symptom burden and to improve survival. In other words live a longer and better life during and after chemotherapy. Direct effects of the cachexia intervention are expected to be reduction of weight and muscle loss, and improved physical activity and quality of life.

Disease
Cancer
Study phase
III
ECRIN support role
Monitoring
Regulatory and ethical submission
Study/trial status
Recruitment/follow-up
Expected patient number
240 patients
Sponsor
Norwegian University of Science and Technology
Sponsor type
Academic
Principal investigator (PI)
Stein Kaasa, Ken Fearon
Current participating countries
Norway
Switzerland
United Kingdom
Trial identifier(s)
NCT
NCT02330926
EudraCT
2013-002282-19
Sponsor's Protocol Code Number
MENAC-2013-05

Spinal cord injury is a severe and devastating neurological disorder that leaves patients with permanent paralysis of the body. No treatment is available today to regenerate interrupted nerve fibers and repair the damaged spinal cord. The incidence of spinal cord injury is about newly injured 10’000 people per year in the EU, and due to an almost normal life expectancy more than 200’000 patients are living with a spinal cord injury in the EU. The impact on the individual quality of life is high, and social costs are enormous. Recent preclinical research in animal models succeeded to greatly enhance axonal sprouting, fiber regeneration and neuroplasticity following injuries of brain and spinal cord. These results warrant translation now to patients suffering from acute spinal cord injury. A previous phase I clinical study using intrathecal application of a nerve fiber growth promoting antibody against the growth inhibitory protein Nogo-A has shown in patients with complete spinal cord injury that this treatment is safe and well tolerated. The present study will enroll patients with various degrees of complete to incomplete acute spinal cord injury for a double-blind, placebo-controlled trial to test the efficacy of this antibody therapy to improve motor outcome and quality of life of tetraplegic patients. The enrollment of patients with different degrees of spinal cord injury is considered essential to reveal drug activity and eventual proof of concept in a broad patient population. Advancements in clinical trial design, improved prediction algorithms of clinical outcomes and development of surrogate markers (in cerebro-spinal fluid/serum and by neuroimaging) will allow for scrutinizing the effectiveness of this novel treatment in an unprecedented way. A positive outcome of this trial will represent a breakthrough for the future therapy of spinal cord injuries and beyond (traumatic brain injury, stroke, multiple sclerosis).

Disease
Spinal cord injury
Study phase
II
ECRIN support role
Monitoring
Regulatory and ethical submission
Study/trial status
Start-up phase
Expected patient number
180 patients
Sponsor
KKS Heidelberg
Sponsor type
Academic
Principal investigator (PI)
Armin Curt
Current participating countries
Czech Republic
Germany
Italy
Spain
Switzerland

This clinical trial involves two comparative analyses:

  • Comparison of efficacy in terms of superiority of hBM-MSCs + biomaterial (both experimental arms, low and high doses) versus iliac crest autologus graft (active comparator arm). The principal endpoint is bone consolidation at one year, defined as a combination of clinical and radiological improvements: radiological consolidation (considered as a new bone formation across the fracture site visible in 3/4 cortices, on at least 3/4 views, qualitative analysis) without pain (with and without weight bearing) and without further reoperation in the callus site.
  • Comparison of efficacy in terms of non-inferiority (target delta of 0.10 points) of low dose hBM-MSC+Biomaterial versus  high dose of hBM-MSC+Biomaterial. The principal endpoint is the radiological consolidation, measured in a scale from 0 to 1, considering the mean consolidation of 0.6875 points (quantitative analysis).
Disease
Long bone non-union (pseudoarthrosis)
Study phase
III
ECRIN support role
Work package leader
Trial management
Study/trial status
Start-up phase
Expected patient number
108 patients
Sponsor
Universidad Autónoma de Madrid
Sponsor type
Academic
Principal investigator (PI)
Enrique González Barrena
Current participating countries
France
Germany
Italy
Spain
Trial identifier(s)
EudraCT
2015-000431-32

PAPA-ARTIS is a phase II trial to demonstrate that a staged treatment approach can reduce paraplegia and mortality dramatically. It can be expected to have both a dramatic impact on the individual patient's quality of life if saved from a wheelchair, and also upon financial systems through savings in; 1) lower costs in EU health care; 2) lower pay-outs in disability insurance (est. at 500k in Year 1), and; 3) loss of economic output from unemployment. Approx. 2500 patients a year in Europe undergo these high risk operations with a cumulative paraplegia rate of over 15%; therefore >100M per year in costs can be avoided and significantly more considering the expected elimination of type II endoleaks.

Study phase
II
Study/trial status
Start-up phase
Sponsor
University of Leipzig (ULEI)
Sponsor type
Academic
Current participating countries
France
Germany
Netherlands
Poland
Sweden
Switzerland
United Kingdom

Achalasia is a rare esophageal disorder which is characterized by a loss of esophageal motoneurons and impaired gastrointestinal peristalsis and food transit. Peroral Endoscopic Myotomy (POEM) is a new endosurgical technique for achalasia in which a surgical myotomy is created using a flexible endoscope through the mouth, completely avoiding any skin incisions. The aim of this study is to compare short and long-term feasibility, safety and efficacy of endoscopic (POEM) with laparoscopic myotomy (Heller myotomy) in the treatment of achalasia.

Disease
Achalasia
Study phase
III
ECRIN support role
Monitoring
Study/trial status
Recruitment/follow-up
Actual trial start date
Expected patient number
240 patients
Sponsor
University Medical Centre Hamburg
Sponsor type
Academic
Principal investigator (PI)
Thomas Roesch
Current participating countries
Belgium
Czech Republic
Germany
Italy
Netherlands
Sweden
Main publications
Campos GM, Vittinghoff E, Rabl C, Takata M, Gadenstätter M, Lin F, Ciovica R. Endoscopic and surgical treatments for achalasia: a systematic review and meta-analysis. Ann Surg. 2009 Jan,249(1):45-57. doi: 10.1097/SLA.0b013e31818e43ab. Review. von Rahden BH, Germer CT. [Laparoscopic myotomy for achalasia is clearly superior to the endoscopic treatment]. Chirurg. 2010 Jan,81(1):69-70. doi: 10.1007/s00104-009-1840-7. German. Rebecchi F, Giaccone C, Farinella E, Campaci R, Morino M. Randomized controlled trial of laparoscopic Heller myotomy plus Dor fundoplication versus Nissen fundoplication for achalasia: long-term results. Ann Surg. 2008 Dec,248(6):1023-30. doi: 10.1097/SLA.0b013e318190a776. Ortiz A, de Haro LF, Parrilla P, Lage A, Perez D, Munitiz V, Ruiz D, Molina J. Very long-term objective evaluation of heller myotomy plus posterior partial fundoplication in patients with achalasia of the cardia. Ann Surg. 2008 Feb,247(2):258-64. doi: 10.1097/SLA.0b013e318159d7dd. Perretta S, Dallemagne B, Allemann P, Marescaux J. Multimedia manuscript. Heller myotomy and intraluminal fundoplication: a NOTES technique. Surg Endosc. 2010 Nov,24(11):2903. doi: 10.1007/s00464-010-1073-3. Epub 2010 Apr 29. Erratum in: Surg Endosc.2010 Nov,24(11):2904. Alleman, Pierre [corrected to Allemann, Pierre]. Pasricha PJ, Hawari R, Ahmed I, Chen J, Cotton PB, Hawes RH, Kalloo AN, Kantsevoy SV, Gostout CJ. Submucosal endoscopic esophageal myotomy: a novel experimental approach for the treatment of achalasia. Endoscopy. 2007 Sep,39(9):761-4. Inoue H, Minami H, Kobayashi Y, Sato Y, Kaga M, Suzuki M, Satodate H, Odaka N, Itoh H, Kudo S. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. 2010 Apr,42(4):265-71. doi: 10.1055/s-0029-1244080. Epub 2010 Mar 30. von Renteln D, Inoue H, Minami H, Werner YB, Pace A, Kersten JF, Much CC, Schachschal G, Mann O, Keller J, Fuchs KH, Rösch T. Peroral endoscopic myotomy for the treatment of achalasia: a prospective single center study. Am J Gastroenterol. 2012 Mar,107(3):411-7. doi: 10.1038/ajg.2011.388. Epub 2011 Nov 8. Swanström LL, Rieder E, Dunst CM. A stepwise approach and early clinical experience in peroral endoscopic myotomy for the treatment of achalasia and esophageal motility disorders. J Am Coll Surg. 2011 Dec,213(6):751-6. doi: 10.1016/j.jamcollsurg.2011.09.001. Epub 2011 Oct 13.
Trial identifier(s)
NCT
NCT01601678

Elderly patients have a high risk of complications after stroke, such as infections or fever. This study aims to assess whether preventive treatment in the first four days of hospitalisation with ceftriaxone, paracetamol, and/or metoclopramide prevents the most common complications and reduce the risk of death or long-term disability compared to standard care alone.

Disease
Stroke
Study phase
III
ECRIN support role
Monitoring
Funding application support
Study/trial status
Recruitment/follow-up
Actual trial start date
Expected patient number
3800 patients
Sponsor
Universitair Medisch Centrum Utrecht
Sponsor type
Academic
Principal investigator (PI)
Bart van der Worp
Current participating countries
Estonia
France
Germany
Hungary
Italy
Netherlands
Norway
Poland
United Kingdom

The PROOF project now seeks to demonstrate that NBHO (high-flow 100% oxygen at >45 L/min via a non-rebreather mask, or FiO2=1.0 for intubation/ventilation) reduces infarct growth from baseline to 24 hours compared to standard treatment if administered at 3 hours after onset of anterior circulation IS, in patients with proximal vessel occlusion and salvageable tissue at risk. The study is multi-center, adaptive phase-IIb, randomized, open-label with blinded-endpoint (PROBE design).

The primary efficacy criterion will be infarct growth from baseline to 24 hours. Secondary endpoints will be NIHSS 24h, categorical shift in the pre-stroke modified Rankin Score, QoL and cognition at day 90. Potential surrogate biomarkers, health economics and societal impacts will be assessed. If NBHO proves its neuroprotective potential in this selected population, phase-III trials in all IS patients may be undertaken. Considering its low costs and ease of use, NBHO may impact stroke care worldwide.

Study phase
IIb
Study/trial status
Start-up phase
Sponsor
Eberhard Karls University, Tübingen
Sponsor type
Academic
Current participating countries
Belgium
Czech Republic
Finland
France
Germany
Spain
Sweden
Switzerland

The aim of this study is to establish which treatment is best for children with Electrical Status Epilepticus in Sleep (ESES) syndrome, by treating 130 children with ESES syndrome with steroids (inflammation inhibitors) or clobazam and evaluating change in cognitive functioning after 6 and 18 months.

Disease
Encephalopathy with Electrical Status Epilepticus in Sleep (ESES Syndrome)
Study phase
II
ECRIN support role
Advice and information
Monitoring
Local pharmacovigilance
Local project management
Regulatory and ethical submission
Study/trial status
Recruitment/follow-up
Actual trial start date
Expected patient number
140 patients
Sponsor
University Medical Centre Utrecht
Sponsor type
Academic
Principal investigator (PI)
Floor E. Jansen
Current participating countries
Belgium
Bulgaria
Denmark
Finland
France
Germany
Italy
Netherlands
Romania
Spain
Switzerland
United Kingdom
Trial identifier(s)
ISRCTN

The primary outcome of this trial is to evaluate the effectiveness of intradiscal injection of bone marrow mesenchymal stromal/stem cells (BM-MSCs) in reducing chronic lower back pain (LBP) using the visual analog scale (VAS) and functional status (Oswestry scale) after 12 months of treatment, defining responders in case of at least 20% improvement in VAS or Oswestry scale at month 12 compared to a baseline with absolute change of 20 mm on a 100 mm scale.

Disease
chronic lower back pain
Study phase
IIb
ECRIN support role
Monitoring
Funding application support
Local pharmacovigilance
Local project management
Regulatory and ethical submission
Study/trial status
Start-up phase
Actual trial start date
Expected patient number
112 patients
Sponsor
Montpellier University Hospital
Sponsor type
Academic
Principal investigator (PI)
Pr Christian JORGENSEN
Trial identifier(s)
EudraCT
2017-002092-25

In a multicenter, open-label, randomized controlled trial we aim to demonstrate that an early switch from intravenous to oral antimicrobial therapy is non-inferior to a conventional 14-days course of intravenous therapy regarding efficacy and safety. An early switch from intravenous to oral therapy would provide several benefits such as earlier discharge, fewer adverse reactions associated with intravenous therapy, increased quality of life, and cost savings.

Disease
Staphylococcus aureus bloodstream infection (SAB)
Study phase
III
ECRIN support role
Advice and information
Monitoring
Local pharmacovigilance
Regulatory and ethical submission
Study/trial status
Recruitment/follow-up
Expected patient number
430 patients
Sponsor
University of Cologne
Sponsor type
Academic
Principal investigator (PI)
Achim J. Kaasch
Current participating countries
Germany
Netherlands
Spain
United Kingdom
Trial identifier(s)
NCT
NCT01792804

The purpose of this study is to evaluate the efficacy of a polypill strategy containing aspirin (100 mg), ramipril (2.5, 5 or 10 mgs), and atorvastatin (40 mgs) compared with the standard of care (usual care according to the local clinical practices at each participating country) in secondary prevention of major cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal ischemic stroke, and urgent revascularization) in elderly patients with a recent myocardial infarction.

Disease
Cardiovascular disease
Study phase
III
ECRIN support role
Local pharmacovigilance
Study/trial status
Start-up phase
Actual trial start date
Expected patient number
3206 patients
Sponsor
Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC)
Sponsor type
Academic
Principal investigator (PI)
Valentín Fuster
Current participating countries
Czech Republic
France
Germany
Hungary
Italy
Poland
Spain

Ivermectin is currently the best drug to cure strongyloidiasis, but the standard single dose of 200 mcg/kg is probably not enough to guarantee a cure. As strongyloidiasis can be fatal in immunosuppressed patients, it is mandatory to define the optimal dosage to eradicate the parasite. The aim of this study is to define the most effective dose schedule of ivermectin to cure strongyloidiasis.

Disease
Strongyloidiasis
Study phase
III
ECRIN support role
Advice and information
Monitoring
Data management
Study/trial status
Recruitment/follow-up
Actual trial start date
Expected patient number
400 patients
Sponsor
Centro per le Malattie Tropicali
Sponsor type
Academic
Principal investigator (PI)
Dora Buonfrate
Current participating countries
Belgium
Italy
Peru
Spain
United Kingdom
Trial identifier(s)
NCT
NCT01570504

Huntington's disease is an autosomal dominant disease characterised by movement disorders and cognitive and neuropsychiatric disturbances. The clinical features usually emerge between 30 and 50 years of age and there is currently no curative treatment. Brain energy deficiency plays an important role in the pathophysiology of the disease. This study asks whether the administration of triheptanoin can effectively improve Huntington's disease as assessed by MRI, in vivo spectroscopy and clinical evaluation.

Disease
Huntington's disease
Study phase
II
ECRIN support role
Monitoring
Regulatory and ethical submission
Study/trial status
Recruitment/follow-up
Actual trial start date
Expected patient number
100 patients
Sponsor
Institut National de la Sante et de la Recherche Medicale (INSERM)
Sponsor type
Industry – large company
Principal investigator (PI)
Fanny Mochel
Current participating countries
France
Netherlands
Trial identifier(s)
EudraCT
2014-005112-42
NCT
NCT02453061

VISION-DMD (Phase 2 Clinical Trials of VBP15: An Innovative Steroid-like Intervention on Duchenne Muscular Dystrophy, DMD) is a Phase 2a and 2b randomised, double-blind, parallel placebo- and active-controlled study. It will assess the safety and toxicity (phase 2a) and safety and efficacy (phase 2b) of the orphan drug VBP15 in ambulatory boys with Duchenne muscular dystrophy (DMD), a rare recessive X-linked form of muscular dystrophy. Funded by Horizon 2020 and the sponsor, Reveragen Biopharma Limited, the project aims to advance clinical development of VBP15 as a new therapy to revolutionise care for all patients with DMD by 2020. The study will be carried out over 18 to 24 months in approximately 15 countries and 30 international study sites. The phase 2a study will be conducted at approximately 10 U.S. study sites. The phase 2b study, supported by ECRIN, will be conducted at approximately 30 international study sites in 14 different countries (UK, France, Italy, Spain, Belgium, Netherlands, Denmark, Sweden, Switzerland, Poland, Czech Republic, Turkey, Israel, and Australia).

Disease
Duchenne muscular dystrophy
Study phase
IIb
Study/trial status
Start-up phase
Expected patient number
100 patients
Sponsor
Reveragen
Sponsor type
Industry – SME
Principal investigator (PI)
Michela Guglieri
Current participating countries
Australia
Belgium
Czech Republic
Denmark
France
Germany
Israel
Italy
Netherlands
Poland
Spain
Sweden
Turkey
United Kingdom

Past Trials

Intravenous hydroxyethyl starch (HES) is routinely used to stabilise patients with severe sepsis. Since high-molecular-weight HES may cause acute kidney failure in sepsis patients, it has been replaced by low-molecular-weight HES 130/0.4. What are the effects of HES 130/0.4 on mortality and endstage kidney failure in patients with severe sepsis?

Disease
Sepsis
Study phase
III
ECRIN support role
Monitoring
ECRIN-On-Board
Study/trial status
Completed
Actual trial start date
Actual trial end date
Expected patient number
804 patients
Sponsor
Rigshospitalet, University of Copenhagen
Sponsor type
Academic
Principal investigator (PI)
Anders Perner
Current participating countries
Denmark
Finland
Iceland
Main publications
Perner A, Haase N, Guttormsen AB, Tenhunen J, Klemenzson G, Åneman A, Madsen KR, Møller MH, Elkjær JM, Poulsen LM, Bendtsen A, Winding R, Steensen M, Berezowicz P, Søe-Jensen P, Bestle M, Strand K, Wiis J, White JO, Thornberg KJ, Quist L, Nielsen J, Andersen LH, Holst LB, Thormar K, Kjældgaard AL, Fabritius ML, Mondrup F, Pott FC, Møller TP, Winkel P, Wetterslev J, 6S Trial Group, Scandinavian Critical Care Trials Group. Hydroxyethyl starch 130/0.42 versus Ringer's acetate in severe sepsis. N Engl J Med. 2012 Jul 12,367(2):124-34. doi: 10.1056/NEJMoa1204242. Epub 2012 Jun 27. Erratum in: N Engl J Med. 2012 Aug 2,367(5):481.
Müller RG, Haase N, Wetterslev J, Perner A. Effects of hydroxyethyl starch in subgroups of patients with severe sepsis: exploratory post-hoc analyses of a randomised trial. Intensive Care Med. 2013 Nov,39(11):1963-71. doi: 10.1007/s00134-013-3090-x. Epub 2013 Sep 14.
Perner A, Haase N, Winkel P, Guttormsen AB, Tenhunen J, Klemenzson G, Müller RG, Aneman A, Wetterslev J. Long-term outcomes in patients with severe sepsis randomised to resuscitation with hydroxyethyl starch 130/0.42 or Ringer's acetate. Intensive Care Med. 2014 Jul,40(7):927-34. doi: 10.1007/s00134-014-3311-y. Epub 2014 May 8.
Ostrowski SR, Haase N, Müller RB, Møller MH, Pott FC, Perner A, Johansson PI. Association between biomarkers of endothelial injury and hypocoagulability in patients with severe sepsis: a prospective study. Crit Care. 2015 Apr 24,19:191. doi: 10.1186/s13054-015-0918-5.
Perner A, Haase N, Wetterslev J, Aneman A, Tenhunen J, Guttormsen AB, Klemenzson G, Pott F, Bødker KD, Bådstøløkken PM, Bendtsen A, Søe-Jensen P, Tousi H, Bestle M, Pawlowicz M, Winding R, Bülow HH, Kancir C, Steensen M, Nielsen J, Fogh B, Madsen KR, Larsen NH, Carlsson M, Wiis J, Petersen JA, Iversen S, Schøidt O, Leivdal S, Berezowicz P, Pettilä V, Ruokonen E, Klepstad P, Karlsson S, Kaukonen M, Rutanen J, Karason S, Kjældgaard AL, Holst LB, Wernerman J, Scandinavian Critical Care Trials Group. Comparing the effect of hydroxyethyl starch 130/0.4 with balanced crystalloid solution on mortality and kidney failure in patients with severe sepsis (6S--Scandinavian Starch for Severe Sepsis/Septic Shock trial): study protocol, design and rationale for a double-blinded, randomised clinical trial. Trials. 2011 Jan 27,12:24. doi: 10.1186/1745-6215-12-24.
Trial identifier(s)
NCT
NCT00962156

A randomised double blind dose non-inferiority trial of a daily dose of 600mg versus 300mg versus 100mg of enteric coated aspirin as a cancer preventive in carriers of a germline pathological mismatch repair gene defect, Lynch Syndrome. Project 3 in the Cancer Prevention Programme (CaPP3).

Disease
Lynch Syndrome
Study phase
III
Study/trial status
ECRIN no longer involved
Expected patient number
3000 patients
Current participating countries
Australia
Denmark
Finland
Germany
Sweden
United Kingdom

Current pertussis (whooping cough) acellular vaccine strategies do not protect very young infants. Vaccination using a genetically modified B. pertussis strain administered nasally should mimic infection and induce strong immune responses, even in infants, without causing disease. Is this vaccine safe in humans and does it illicit sufficient immune response?

Disease
Pertussis
Study phase
I
ECRIN support role
Advice and information
Monitoring
Local pharmacovigilance
Regulatory and ethical submission
Study/trial status
Trial/study results published
Actual trial start date
Expected patient number
48 patients
Sponsor
INSERM
Sponsor type
Academic
Principal investigator (PI)
Camille Locht
Current participating countries
France
Sweden
Main publications
Thorstensson R, Trollfors B, Al-Tawil N, Jahnmatz M, Bergström J, Ljungman M, Törner A, Wehlin L, Van Broekhoven A, Bosman F, Debrie AS, Mielcarek N, Locht C. A phase I clinical study of a live attenuated Bordetella pertussis vaccine--BPZE1; a single centre, double-blind, placebo-controlled, dose-escalating study of BPZE1 given intranasally to healthy adult male volunteers. PLoS One. 2014 Jan 8;9(1):e83449. doi: 10.1371/journal.pone.0083449. eCollection 2014.
Trial identifier(s)
NCT
NCT01188512
EudraCT
2010-019936-11

In patients with liver metastasis from colorectal cancer who will undergo liver surgery, perioperative chemotherapy using the drug combination FOLFOX is standard. This study aims to evaluate whether or not the addition of either Bevacizumab or Panitumumab to FOLFOX increase progression-free survival compared with FOLFOX alone?

Disease
Liver cancer, Colorectal cancer metastatic, Liver metastases, KRAS wild type colorectal cancer
Study phase
II
ECRIN support role
Monitoring
Study/trial status
Withdrawn/cancelled
Expected patient number
360 patients
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
Sponsor type
Industry – large company
Principal investigator (PI)
Bernard Nordlinger, Stephane Benoist
Current participating countries
Austria
Belgium
France
Germany
Netherlands
Norway
Spain
Switzerland
United Kingdom
Trial identifier(s)
NCT
NCT01508000
EudraCT
2010-019238-29

Non-alcoholic fatty liver disease (NAFLD) is responsible for an increasing prevalence of liver disease and is becoming the commonest cause of liver disease in the western world. NAFLD is recognised to be the hepatic manifestation of the metabolic syndrome, which is a cluster of metabolic abnormalities characterised by abdominal obesity, insulin resistance, impaired glucose metabolism, hypertension and dyslipidaemia. In its mildest form there is an accumulation of fat in the liver (steatosis) without any liver damage, however in many cases it progresses to non-alcoholic steatohepatitis (NASH), and cirrhosis. Current treatment options for NASH are limited in efficacy, necessitating the development of more effective options. New agents such as Glucagon-like Peptide-1 (GLP-1) agonists that improve diabetic control and facilitate weight loss have been suggested as therapies in NASH. No published studies to date have assessed the impact of the GLP-1 agonist, Liraglutide, on liver histology and metabolism in obese patients with NASH. This study hypothesises that treatment with liraglutide will result in a significant improvement in histological disease activity in overweight patients with NASH, in the presence or absence of Type 2 Diabetes (T2DM)

Disease
Steatohepatitis
Study phase
II
Study/trial status
Completed
Expected patient number
52 patients
Sponsor
University of Birmingham, Wellcome Trust, Novo Nordisk A/S
Sponsor type
Academic
Principal investigator (PI)
Philip N Newsome
Current participating countries
United Kingdom
Main publications
Armstrong MJ, Gaunt P, Aithal GP, Barton D, Hull D, Parker R, Hazlehurst JM, Guo K, LEAN trial team, Abouda G, Aldersley MA, Stocken D, Gough SC, Tomlinson JW, Brown RM, Hübscher SG, Newsome PN. Liraglutide safety and efficacy in patients with non-alcoholic steatohepatitis (LEAN): a multicentre, double-blind, randomised, placebo-controlled phase 2 study. Lancet. 2016 Feb 13,387(10019):679-90. doi: 10.1016/S0140-6736(15)00803-X. Epub 2015 Nov 20. Armstrong MJ, Hull D, Guo K, Barton D, Hazlehurst JM, Gathercole LL, Nasiri M, Yu J, Gough SC, Newsome PN, Tomlinson JW. Glucagon-like peptide 1 decreases lipotoxicity in non-alcoholic steatohepatitis. J Hepatol. 2016 Feb,64(2):399-408. doi: 10.1016/j.jhep.2015.08.038. Epub 2015 Sep 21. Armstrong MJ, Barton D, Gaunt P, Hull D, Guo K, Stocken D, Gough SC, Tomlinson JW, Brown RM, Hübscher SG, Newsome PN, LEAN trial team. Liraglutide efficacy and action in non-alcoholic steatohepatitis (LEAN): study protocol for a phase II multicentre, double-blinded, randomised, controlled trial. BMJ Open. 2013 Nov 4,3(11):e003995. doi: 10.1136/bmjopen-2013-003995.
Trial identifier(s)
NCT
NCT01237119

This is a multicentre European double-blind, randomized and controlled trial with 2 parallel groups (1 study medication, 1 placebo) in order to analyse the impact of ACE inhibitors (ACEi) in subjects who carry a mutation but have not yet developed DCM (dilated cardiomyopathy). Objective of the trial: Study the impact of ACE inhibitors (ACEi) in subjects who carry a mutation (leading to a genetic form of heart failure) but have not yet developed DCM.

Disease
Dilated cardiomyopathy
Study phase
III
Study/trial status
Withdrawn/cancelled
Sponsor
Institut National de la Sante et de la Recherche Medicale (INSERM)
Sponsor type
Academic
Principal investigator (PI)
Philippe Charron
Current participating countries
Denmark
France
Germany
Italy
Netherlands
Spain
United Kingdom
Trial identifier(s)
NCT
NCT01583114

The primary objective of the SafeBoosC trial is to examine if it is possible to stabilise the cerebral oxygenation of extremely preterm infants during the first 72 hours of life through the application of cerebral NIRS oximetry and implementation of an rStO2-specific clinical treatment guideline. We hypothesise that by using the specified treatment guideline to respond to cerebral monitoring readings outside the target range, we would reduce the burden of hypo- and hyperoxia and consequently reduce brain injury.

This is an investigator-initiated randomised, blinded, multinational, phase II feasibility clinical trial involving preterm infants from 12 European countries.

Disease
Brain disease
Study phase
II
Study/trial status
Trial/study results published
Sponsor
Gorm Greisen, Rigshospitalet, Denmark
Sponsor type
Academic
Principal investigator (PI)
Gorm Greisen
Current participating countries
Austria
Denmark
France
Germany
Ireland
Italy
Netherlands
Spain
Switzerland
United Kingdom
Main publications
Riera J, Hyttel-Sorensen S, Bravo MC, Cabañas F, López-Ortego P, Sanchez L, Ybarra M, Dempsey E, Greisen G, Austin T, Claris O, Fumagalli M, Gluud C, Lemmers P, Pichler G, Plomgaard AM, van Bel F, Wolf M, Pellicer A. The SafeBoosC phase II clinical trial: an analysis of the interventions related with the oximeter readings. Arch Dis Child Fetal Neonatal Ed. 2016 Jul;101(4):F333-8. doi: 10.1136/archdischild-2015-308829. Epub 2015 Dec 8.
Hyttel-Sorensen S, Pellicer A, Alderliesten T, Austin T, van Bel F, Benders M, Claris O, Dempsey E, Franz AR, Fumagalli M, Gluud C, Grevstad B, Hagmann C, Lemmers P, van Oeveren W, Pichler G, Plomgaard AM, Riera J, Sanchez L, Winkel P, Wolf M, Greisen G. Cerebral near infrared spectroscopy oximetry in extremely preterm infants: phase II randomised clinical trial. BMJ. 2015 Jan 5;350:g7635. doi: 10.1136/bmj.g7635.
Hyttel-Sorensen S, Austin T, van Bel F, Benders M, Claris O, Dempsey E, Fumagalli M, Greisen G, Grevstad B, Hagmann C, Hellström-Westas L, Lemmers P, Lindschou J, Naulaers G, van Oeveren W, Pellicer A, Pichler G, Roll C, Skoog M, Winkel P, Wolf M, Gluud C. A phase II randomized clinical trial on cerebral near-infrared spectroscopy plus a treatment guideline versus treatment as usual for extremely preterm infants during the first three days of life (SafeBoosC): study protocol for a randomized controlled trial. Trials. 2013 May 1;14:120. doi: 10.1186/1745-6215-14-120.
Trial identifier(s)
NCT
NCT01590316

This study is designed to determine whether micafungin is as efficacious as the current standard of fluconazole, to compare the safety of the two drugs in the treatment of proven neonatal candidiasis.

It is also designed to further elucidate the pharmacokinetics of the two products in the growing and developing neonate and premature infant.

Disease
Candidiasis
ECRIN support role
Monitoring
Regulatory and ethical submission
Study/trial status
Withdrawn/cancelled
Expected patient number
100 patients
Sponsor
Institut National de la Sante et de la Recherche Medicale (INSERM)
Sponsor type
Academic
Principal investigator (PI)
Evelyne Jaczq-Aigrain
Current participating countries
Belgium
France
Italy
Netherlands
Spain
Trial identifier(s)
NCT
NCT02282176
EudraCT
2012-001916-41

The aim of the TINN2 study is to evaluate the efficacy of azithromycin in prevention of bronchopulmonary dysplasia in preterm neonates.

Disease
Paediatric lung disease, bronchopulmonary dysplasia
Study phase
III
ECRIN support role
Monitoring
Regulatory and ethical submission
Study/trial status
Withdrawn/cancelled
Expected patient number
810 patients
Sponsor
Institut National de la Sante et de la Recherche Medicale (INSERM)
Sponsor type
Academic
Principal investigator (PI)
Evelyne Jaczq-Aigrain
Current participating countries
France
Germany
Hungary
Italy
Netherlands
Sweden
United Kingdom
Main publications
Turner MA, Jacqz-Aigrain E, Kotecha S. Azithromycin, Ureaplasma and chronic lung disease of prematurity: a case study for neonatal drug development. Arch Dis Child. 2012 Jun,97(6):573-7. doi: 10.1136/adc.2010.195180. Epub 2011 Jun 22. Review. Pansieri C, Pandolfini C, Elie V, Turner MA, Kotecha S, Jacqz-Aigrain E, Bonati M. Ureaplasma, bronchopulmonary dysplasia, and azithromycin in European neonatal intensive care units: a survey. Sci Rep. 2014 Feb 12,4:4076. doi: 10.1038/srep04076. Lowe J, Watkins WJ, Edwards MO, Spiller OB, Jacqz-Aigrain E, Kotecha SJ, Kotecha S. Association between pulmonary ureaplasma colonization and bronchopulmonary dysplasia in preterm infants: updated systematic review and meta-analysis. Pediatr Infect Dis J. 2014 Jul,33(7):697-702. doi: 10.1097/INF.0000000000000239. Review.
Trial identifier(s)
EudraCT
2013-003889-14
NCT
NCT02282176

Patients with blood poisoning - sepsis - often receive blood transfusions in the intensive care unit. The evidence that blood transfusion leads to improved outcome is limited and the blood may be harmful to some of these patients. To bridge the gap between clinical practice and evidence, a large randomised clinical trial is needed to document the efficacy and safety of RBC transfusion in these very sick patients.

Disease
Septic shock
Study phase
III
ECRIN support role
Advice and information
Monitoring
Funding application support
Local pharmacovigilance
Local project management
Regulatory and ethical submission
Data management
Study/trial status
Completed
Expected patient number
1005 patients
Sponsor
Scandinavian Critical Care Trials Group
Sponsor type
Academic
Principal investigator (PI)
Anders Perner
Current participating countries
Denmark
Finland
Iceland
Norway
Sweden
Main publications
Holst LB, Haase N, Wetterslev J, Wernerman J, Guttormsen AB, Karlsson S, Johansson PI, Aneman A, Vang ML, Winding R, Nebrich L, Nibro HL, Rasmussen BS, Lauridsen JR, Nielsen JS, Oldner A, Pettilä V, Cronhjort MB, Andersen LH, Pedersen UG, Reiter N, Wiis J, White JO, Russell L, Thornberg KJ, Hjortrup PB, Müller RG, Møller MH, Steensen M, Tjäder I, Kilsand K, Odeberg-Wernerman S, Sjøbø B, Bundgaard H, Thyø MA, Lodahl D, Mærkedahl R, Albeck C, Illum D, Kruse M, Winkel P, Perner A; TRISS Trial Group; Scandinavian Critical Care Trials Group. Lower versus higher hemoglobin threshold for transfusion in septic shock. N Engl J Med. 2014 Oct 9;371(15):1381-91. doi: 10.1056/NEJMoa1406617. Epub 2014 Oct 1.
Trial identifier(s)
NCT
NCT01485315

Therapeutic hypothermia is recommended for unconscious survivors of out-of-hospital cardiac arrest. Are there differences in mortality, neurological function and adverse events between a target temperature management at 33°C and 36°C for 24 hours after cardiac arrest?

Disease
Cardiac Arrest
Study phase
III
ECRIN support role
Advice and information
Monitoring
Local project management
Study/trial status
Completed
Actual trial start date
Actual trial end date
Expected patient number
950 patients
Sponsor
Helsingborgs Hospital, Sweden
Sponsor type
Academic
Principal investigator (PI)
Niklas Nielsen
Current participating countries
Australia
Czech Republic
Denmark
Finland
Iceland
Italy
Luxembourg
Netherlands
Norway
Sweden
Switzerland
United Kingdom
Main publications
Nielsen N, Wetterslev J, Cronberg T, Erlinge D, Gasche Y, Hassager C, Horn J, Hovdenes J, Kjaergaard J, Kuiper M, Pellis T, Stammet P, Wanscher M, Wise MP, Åneman A, Al-Subaie N, Boesgaard S, Bro-Jeppesen J, Brunetti I, Bugge JF, Hingston CD, Juffermans NP, Koopmans M, Køber L, Langørgen J, Lilja G, Møller JE, Rundgren M, Rylander C, Smid O, Werer C, Winkel P, Friberg H; TTM Trial Investigators. Targeted Temperature Management at 33°C versus 36°C after Cardiac Arrest. N Engl J Med. 2013 Dec 5;369(23):2197-206. doi: 10.1056/NEJMoa1310519. Epub 2013 Nov 17.
Trial identifier(s)
NCT
NCT01020916