Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest (TTM-2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02908308|
Recruitment Status : Active, not recruiting
First Posted : September 20, 2016
Last Update Posted : January 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Out-of-hospital Cardiac Arrest||Procedure: Targeted temperature management to 33°C Procedure: Standard care with early treatment of fever||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1900 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||The clinical team responsible for the participant (physicians, nurses and others) and involved with direct patient care will not be blinded to allocation group due to the inherent difficulty in blinding the intervention and as temperature is a vital sign required for clinical care. Measures will be taken to ensure that the information about allocation will not disseminate beyond the immediate group of caregivers responsible for patient care. A blinded physician will evaluate the patient at 96 hours after randomisation and make a statement on neurological prognosis.|
|Official Title:||Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest (TTM2) - A Randomised Clinical Trial|
|Actual Study Start Date :||November 18, 2017|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||December 2021|
Active Comparator: Normothermia
Standard care with early treatment of fever. Active temperature control with a device will be used if the patient develops a temperature greater than or equal 37.8°C.
Procedure: Standard care with early treatment of fever
Normothermia and standard care - use of a device for temperature control if temperature is greater than or equal to 37.8°C
Targeted temperature management to 33°C for up to 28h.
Procedure: Targeted temperature management to 33°C
Rapid cooling to below 33°C, followed by temperature control at 33°C for up to 28h.
- Mortality [ Time Frame: 180 days ]Landmark mortality at 180 days
- Poor functional outcome [ Time Frame: 180 days ]Assessed using the modified Rankin Scale (mRS), with a score of 4-6 being a poor outcome.
- Days alive outside hospital [ Time Frame: 180 days. ]Number of days alive within 180 days from initial hospital discharge.
- Quality of Life [ Time Frame: 180 days ]Health-related Quality of Life - EQ-5D (VAS scale)
- Quality of Life [ Time Frame: 180 days ]Health-related Quality of Life - EQ-5D (Index value)
- Survival until end of the trial [ Time Frame: 180 days after randmomization of the last patient ]Mortality.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02908308
|Principal Investigator:||Niklas Nielsen, MD, PhD||Helsingborgs lasarett, Region Skåne, Sweden|
|Principal Investigator:||Hans Friberg, MD, PhD||Lund University Hospital, Lund, Sweden|
|Principal Investigator:||Tobias Cronberg, MD, PhD||Lund University Hospital, Lund, Sweden|
|Principal Investigator:||Jan Hovdenes, MD, PhD||Oslo University Hospital, Oslo, Norway|
|Principal Investigator:||Matt P Wise, MD, PhD||University Hospital of Wales, Cardiff, UK|
|Principal Investigator:||Clifton W Callaway, MD, PhD||University of Pittsburgh, Pittsburgh, USA|
|Principal Investigator:||Christian Storm, MD, PhD||Charité University Medicine, Berlin, Germany|
|Principal Investigator:||Alain Cariou, MD, PhD||Université Paris Descartes, France|
|Principal Investigator:||David Erlinge, MD, PhD||Lund University Hospital, Lund, Sweden|
|Principal Investigator:||Christian Rylander, MD, PhD||Sahlgrenska University Hospital, Gothenburg, Sweden|
|Principal Investigator:||Josef Dankiewicz, MD, PhD||Skåne University Hospital, Lund|
|Principal Investigator:||Mauro Oddo, MD, PhD||Université de Lausanne, Lausanne, Switzerland|
|Principal Investigator:||Manoj Saxena, MD, PhD||The George Institute for Global Health, Sydney, Australia|
|Principal Investigator:||Per Nordberg, MD, PhD||Södersjukhuset, Stockholm|
|Principal Investigator:||Fabio Taccone, MD, PhD||Hopital Erasme, Brussles, Belgium|
|Principal Investigator:||Paolo Pelosi, MD, PhD||San Martino University Hospital, Genoa|
|Principal Investigator:||Michael Ioannidis, MD, PhD||Innsbruck University Hospital|
|Principal Investigator:||Jan Belholavek, MD, PhD||Prague University Hospital|
|Principal Investigator:||Paul Young, MD||Wellington Regional Hospital|
|Principal Investigator:||Hans Kirkegaard, MD,PhD||Aarhus University Hospital|
|Principal Investigator:||Alistair Nichol, MD, PhD||Department of Anaesthesia and Intensive Care Medicine, St Vincent's University Hospital|