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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
Sponsor:
Collaborators:
Lund University
Region Skåne - Skånevård SUND
Copenhagen Trial Unit, Center for Clinical Intervention Research
Clinical Trials Sweden, Forum South
Integrated Biobank of Luxembourg
Information provided by (Responsible Party):
Niklas Nielsen, Helsingborgs Hospital

Brief Summary:
ILCOR guidelines recommend Target Temperature Management (TTM) to between 32°C and 36°C after out-of-hospital cardiac arrest, based on low quality evidence. In a previous trial, TTM at 33°C did not confer a survival benefit or improved neurological function, compared to TTM at 36°C. A lower target temperature might be beneficial compared with normothermia and early treatment of fever. Therefore the primary purpose of the TTM2-trial will be to study any differences in mortality, neurological function and quality of life between a target temperature of 33°C and standard care avoiding fever.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1900 participants
Allocation: Randomized
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.
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Experimental: Hypothermia
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.




Primary Outcome Measures :
  1. Mortality [ Time Frame: 180 days ]
    Landmark mortality at 180 days


Secondary Outcome Measures :
  1. Poor functional outcome [ Time Frame: 180 days ]
    Assessed using the modified Rankin Scale (mRS), with a score of 4-6 being a poor outcome.

  2. Days alive outside hospital [ Time Frame: 180 days. ]
    Number of days alive within 180 days from initial hospital discharge.

  3. Quality of Life [ Time Frame: 180 days ]
    Health-related Quality of Life - EQ-5D (VAS scale)

  4. Quality of Life [ Time Frame: 180 days ]
    Health-related Quality of Life - EQ-5D (Index value)

  5. Survival until end of the trial [ Time Frame: 180 days after randmomization of the last patient ]
    Mortality.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Out-of-hospital cardiac arrest
  • Presumed cardiac cause of cardiac arrest
  • Unconscious with a FOUR-score <M4 (not obeying verbal commands)
  • Stable return of spontaneous circulation (20 min)
  • Eligible for intensive care treatment without restrictions
  • Inclusion within 180 minutes of ROSC

Exclusion Criteria:

  • Unwitnessed cardiac arrest with an initial rhythm of asystole
  • Temperature on admission <30°C.
  • On ECMO prior to ROSC
  • Obvious or suspected pregnancy
  • Intracranial bleeding
  • On ECMO prior to ROSC
  • Severe chronic obstructive pulmonary disorder (COPD) with long-term home oxygen therapy

Information from the National Library of Medicine

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


Locations
Show Show 60 study locations
Sponsors and Collaborators
Helsingborgs Hospital
Lund University
Region Skåne - Skånevård SUND
Copenhagen Trial Unit, Center for Clinical Intervention Research
Clinical Trials Sweden, Forum South
Integrated Biobank of Luxembourg
Investigators
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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

Additional Information:
Publications:
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Responsible Party: Niklas Nielsen, MD, PhD, Associate professor, Helsingborgs Hospital
ClinicalTrials.gov Identifier: NCT02908308    
Other Study ID Numbers: TTM-2
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Niklas Nielsen, Helsingborgs Hospital:
Induced hypothermia
Mild induced hypothermia
Therapeutic hypothermia
Cardiac arrest
Out-of-hospital cardiac arrest
Mortality
Neurological function
Randomised clinical trial
Additional relevant MeSH terms:
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Heart Arrest
Out-of-Hospital Cardiac Arrest
Hypothermia
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms