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Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest (TTM-2)

Primary Purpose

Out-of-hospital Cardiac Arrest

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Targeted temperature management to 33°C
Standard care with early treatment of fever
Sponsored by
Helsingborgs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Out-of-hospital Cardiac Arrest focused on measuring Induced hypothermia, Mild induced hypothermia, Therapeutic hypothermia, Cardiac arrest, Out-of-hospital cardiac arrest, Mortality, Neurological function, Randomised clinical trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mayo Clinic Hospital-St. Mary's Campus
  • UPMC-Presbyterian
  • John Hunter Hospital
  • Concord Repatriation General Hospital
  • Liverpool Hospital
  • St Vincent's Hospital
  • Princess Alexandra Hospital
  • Northern Hospital
  • The Alfred
  • Austin Hospital
  • Nepean Hospital
  • Royal North Shore Hospital
  • Innsbruck University Hospital
  • Erasme Hospital
  • Ziekenhuis Oost-Limburg
  • Hradec Kralove Hospital
  • Liberec Hospital
  • General University Hospital
  • Aarhus University Hospital
  • Chu Dupuytren
  • CHU Nantes
  • Cochin University Hospital
  • Lariboisière Hospital
  • Versailles Hospital
  • Charité, Campus Virchow
  • San Martino Hospital
  • Modena NOCSAE Hospital
  • Christchurch Hospital
  • Wellington Hospital
  • Sorlandet Hospital
  • Haukeland Hospital
  • Oslo University Hospital
  • St. Olav's University Hospital
  • Hallands Hospital
  • Skane University Hospital - Lund
  • Skane University Hospital - Malmö
  • Sahlgrenska University Hospital
  • Helsingborgs Hospital
  • Centralsjukhuset i Karlstad
  • Linköping University Hospital
  • Skaraborgs sjukhus
  • Capio St:Göran
  • Södersjukhuset
  • Norra Älvsborgs Länssjukhus (NÄL)
  • Akademiska Sjukhuset
  • Örebro University Hospital
  • University Hospital Bern, Inselspital
  • University Hospital of Lausanne
  • Cardiocentro Ticino
  • Kantonsspital St.Gallen
  • Zurich University Hospital
  • Basildon and Thurrock Hospitals NHS Foundation Trust - Essex CTC
  • Royal Victoria Hospital
  • Birmingham University Hospital
  • Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
  • Bristol Royal Infirmary
  • University Hospital of Wales
  • Manchester Royal Infirmary
  • Queen Alexandra Hospital
  • Royal Berkshire Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Normothermia

Hypothermia

Arm Description

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.

Targeted temperature management to 33°C for up to 28h.

Outcomes

Primary Outcome Measures

Mortality
Landmark mortality at 180 days

Secondary Outcome Measures

Poor functional outcome
Assessed using the modified Rankin Scale (mRS), with a score of 4-6 being a poor outcome.
Days alive outside hospital
Number of days alive within 180 days from initial hospital discharge.
Quality of Life
Health-related Quality of Life - EQ-5D (VAS scale)
Quality of Life
Health-related Quality of Life - EQ-5D (Index value)
Survival until end of the trial
Mortality.

Full Information

First Posted
September 16, 2016
Last Updated
March 30, 2023
Sponsor
Helsingborgs Hospital
Collaborators
Lund University, Region Skåne - Skånevård SUND, Copenhagen Trial Unit, Center for Clinical Intervention Research, Clinical Trials Sweden, Forum South, Integrated Biobank of Luxembourg
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1. Study Identification

Unique Protocol Identification Number
NCT02908308
Brief Title
Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest
Acronym
TTM-2
Official Title
Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest (TTM2) - A Randomised Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 18, 2017 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsingborgs Hospital
Collaborators
Lund University, Region Skåne - Skånevård SUND, Copenhagen Trial Unit, Center for Clinical Intervention Research, Clinical Trials Sweden, Forum South, Integrated Biobank of Luxembourg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The TTM2 trial is a continuation of the collaboration that resulted in the previous Targeted Temperature Management after out-of-hospital cardiac arrest trial (hereafter: TTM1). With its planned size with it will supersede the TTM1 trial as the largest trial on temperature management as a post-cardiac arrest treatment. The TTM1 trial (NCT01020916) was a multicenter, multinational, outcome assessor-blinded, parallel group, randomised clinical trial comparing two strict target temperature regimens of 33°C and 36°C in adult patients, who have sustained return of spontaneous circulation and are unconscious after out-of-hospital cardiac arrest, when admitted to hospital. The trial did not demonstrate any difference in survival until end of trial (Hazard Ratio with a point estimate in favour of 36°C of 1.06 (95% confidence interval 0.89-1.28; P=0.51) or neurologic function at six months after the arrest, measured with CPC and mRS. The planned study is a international, multicenter, parallel group, non-commerical, randomized, superiority trial in which a target temperature om 33°C after cardiac arrest will be compared to normothermia and early treatment of fever. Patients eligible for inclusion will be unconscious adult patients with OHCA of a presumed cardiac cause with stable return of spontaneous circulation. Randomization will be performed by a physician in the emergency department, in the angiography suite or in the intensive care unit via web-based application using permuted blocks with varying sizes, stratified by site. Due to the nature of the intervention, health care staff will not be blinded to the intervention. However, the physicians who will assess outcomes will be blinded to temperature allocation, as will those who perform prognostication. The intervention period will commence at the time of randomization. Cooling in the hypothermia group will achieved by means of cold fluids and state-of-the-art cooling devices (intravascular or body-surface applied closed loop systems). The initial aim will be to achieve a body temperature of 33.0°C. When this has been achieved, the target temperature will be 33°C until 28 hours after randomisation. When 28 hours have passed, gradual rewarming at a rate of 1/3°C per hour will commence, this will allow 12 hours for rewarming. In the normothermia arm the aim will be to avoid a temperature greater than or equal to 37.8°C using conservative measures. If a single temperature of 37.8° or greater is measured, active cooling with a device should be initiated and maintained until 40 hours after randomization. All participants will be sedated, mechanically ventilated and hemodynamically supported throughout the intervention period of 40 hours. Participants in both arms who remain comatose after 40h should be kept at a normothermic level (36.5 - 37.7°C) until 72h after randomization and active warming should be avoided. Participants who remain unconscious four days after randomization will be assessed according to a conservative protocol based on the European Resuscitation Council's recommendations for withdrawal of life sustaining therapies. Follow up will be performed at: 1 month (face-to-face or telephone), Assessment according to the modified Rankin scale (mRS) 6 moths (face-to-face), Assessment according to the mRS-scale. Assessment of health-related quality of life using EQ5D-5L.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out-of-hospital Cardiac Arrest
Keywords
Induced hypothermia, Mild induced hypothermia, Therapeutic hypothermia, Cardiac arrest, Out-of-hospital cardiac arrest, Mortality, Neurological function, Randomised clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
1900 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normothermia
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Hypothermia
Arm Type
Experimental
Arm Description
Targeted temperature management to 33°C for up to 28h.
Intervention Type
Procedure
Intervention Name(s)
Targeted temperature management to 33°C
Intervention Description
Rapid cooling to below 33°C, followed by temperature control at 33°C for up to 28h.
Intervention Type
Procedure
Intervention Name(s)
Standard care with early treatment of fever
Intervention Description
Normothermia and standard care - use of a device for temperature control if temperature is greater than or equal to 37.8°C
Primary Outcome Measure Information:
Title
Mortality
Description
Landmark mortality at 180 days
Time Frame
180 days
Secondary Outcome Measure Information:
Title
Poor functional outcome
Description
Assessed using the modified Rankin Scale (mRS), with a score of 4-6 being a poor outcome.
Time Frame
180 days
Title
Days alive outside hospital
Description
Number of days alive within 180 days from initial hospital discharge.
Time Frame
180 days.
Title
Quality of Life
Description
Health-related Quality of Life - EQ-5D (VAS scale)
Time Frame
180 days
Title
Quality of Life
Description
Health-related Quality of Life - EQ-5D (Index value)
Time Frame
180 days
Title
Survival until end of the trial
Description
Mortality.
Time Frame
180 days after randmomization of the last patient

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niklas Nielsen, MD, PhD
Organizational Affiliation
Helsingborgs lasarett, Region Skåne, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hans Friberg, MD, PhD
Organizational Affiliation
Lund University Hospital, Lund, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tobias Cronberg, MD, PhD
Organizational Affiliation
Lund University Hospital, Lund, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jan Hovdenes, MD, PhD
Organizational Affiliation
Oslo University Hospital, Oslo, Norway
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matt P Wise, MD, PhD
Organizational Affiliation
University Hospital of Wales, Cardiff, UK
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Clifton W Callaway, MD, PhD
Organizational Affiliation
University of Pittsburgh, Pittsburgh, USA
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christian Storm, MD, PhD
Organizational Affiliation
Charité-University Medicine (Berlin, Germany)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alain Cariou, MD, PhD
Organizational Affiliation
Université Paris Descartes, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Erlinge, MD, PhD
Organizational Affiliation
Lund University Hospital, Lund, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christian Rylander, MD, PhD
Organizational Affiliation
Sahlgrenska University Hospital, Gothenburg, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Josef Dankiewicz, MD, PhD
Organizational Affiliation
Skåne University Hospital Lund
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mauro Oddo, MD, PhD
Organizational Affiliation
Université de Lausanne, Lausanne, Switzerland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Manoj Saxena, MD, PhD
Organizational Affiliation
The George Institute for Global Health (Sydney, Australia)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Per Nordberg, MD, PhD
Organizational Affiliation
Södersjukhuset, Stockholm
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fabio Taccone, MD, PhD
Organizational Affiliation
Hopital Erasme, Brussles, Belgium
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paolo Pelosi, MD, PhD
Organizational Affiliation
San Martino University Hospital, Genoa
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Ioannidis, MD, PhD
Organizational Affiliation
Innsbruck University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jan Belholavek, MD, PhD
Organizational Affiliation
Prague University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Young, MD
Organizational Affiliation
Wellington Regional Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hans Kirkegaard, MD,PhD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alistair Nichol, MD, PhD
Organizational Affiliation
Department of Anaesthesia and Intensive Care Medicine, St Vincent's University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Hospital-St. Mary's Campus
City
Rochester
State/Province
New York
ZIP/Postal Code
55905
Country
United States
Facility Name
UPMC-Presbyterian
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
John Hunter Hospital
City
Newcastle
State/Province
New South Wales
Country
Australia
Facility Name
Concord Repatriation General Hospital
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
Liverpool Hospital
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
St Vincent's Hospital
City
Sydney
State/Province
New South Wales
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Northern Hospital
City
Epping
State/Province
Victoria
Country
Australia
Facility Name
The Alfred
City
Melbourne
State/Province
Victoria
Country
Australia
Facility Name
Austin Hospital
City
Melbourne
Country
Australia
Facility Name
Nepean Hospital
City
Sydney
Country
Australia
Facility Name
Royal North Shore Hospital
City
Sydney
Country
Australia
Facility Name
Innsbruck University Hospital
City
Innsbruck
Country
Austria
Facility Name
Erasme Hospital
City
Brussels
Country
Belgium
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
Country
Belgium
Facility Name
Hradec Kralove Hospital
City
Hradec Králové
Country
Czechia
Facility Name
Liberec Hospital
City
Liberec
Country
Czechia
Facility Name
General University Hospital
City
Prague
Country
Czechia
Facility Name
Aarhus University Hospital
City
Aarhus
Country
Denmark
Facility Name
Chu Dupuytren
City
Limoges
Country
France
Facility Name
CHU Nantes
City
Nantes
Country
France
Facility Name
Cochin University Hospital
City
Paris
Country
France
Facility Name
Lariboisière Hospital
City
Paris
Country
France
Facility Name
Versailles Hospital
City
Versailles
Country
France
Facility Name
Charité, Campus Virchow
City
Berlin
Country
Germany
Facility Name
San Martino Hospital
City
Genova
Country
Italy
Facility Name
Modena NOCSAE Hospital
City
Modena
Country
Italy
Facility Name
Christchurch Hospital
City
Christchurch
Country
New Zealand
Facility Name
Wellington Hospital
City
Wellington
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Sorlandet Hospital
City
Arendal
Country
Norway
Facility Name
Haukeland Hospital
City
Bergen
Country
Norway
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway
Facility Name
St. Olav's University Hospital
City
Trondheim
Country
Norway
Facility Name
Hallands Hospital
City
Halmstad
State/Province
Halland
ZIP/Postal Code
302 33
Country
Sweden
Facility Name
Skane University Hospital - Lund
City
Lund
State/Province
Skåne
ZIP/Postal Code
22185
Country
Sweden
Facility Name
Skane University Hospital - Malmö
City
Malmö
State/Province
Skåne
ZIP/Postal Code
22185
Country
Sweden
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
Country
Sweden
Facility Name
Helsingborgs Hospital
City
Helsingborg
ZIP/Postal Code
251 87
Country
Sweden
Facility Name
Centralsjukhuset i Karlstad
City
Karlstad
ZIP/Postal Code
652 30
Country
Sweden
Facility Name
Linköping University Hospital
City
Linköping
Country
Sweden
Facility Name
Skaraborgs sjukhus
City
Skövde
Country
Sweden
Facility Name
Capio St:Göran
City
Stockholm
Country
Sweden
Facility Name
Södersjukhuset
City
Stockholm
Country
Sweden
Facility Name
Norra Älvsborgs Länssjukhus (NÄL)
City
Trollhättan
ZIP/Postal Code
461 73
Country
Sweden
Facility Name
Akademiska Sjukhuset
City
Uppsala
Country
Sweden
Facility Name
Örebro University Hospital
City
Örebro
Country
Sweden
Facility Name
University Hospital Bern, Inselspital
City
Bern
Country
Switzerland
Facility Name
University Hospital of Lausanne
City
Lausanne
Country
Switzerland
Facility Name
Cardiocentro Ticino
City
Lugano
Country
Switzerland
Facility Name
Kantonsspital St.Gallen
City
Saint Gallen
Country
Switzerland
Facility Name
Zurich University Hospital
City
Zürich
Country
Switzerland
Facility Name
Basildon and Thurrock Hospitals NHS Foundation Trust - Essex CTC
City
Basildon
Country
United Kingdom
Facility Name
Royal Victoria Hospital
City
Belfast
Country
United Kingdom
Facility Name
Birmingham University Hospital
City
Birmingham
Country
United Kingdom
Facility Name
Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
City
Bournemouth
Country
United Kingdom
Facility Name
Bristol Royal Infirmary
City
Bristol
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
Country
United Kingdom
Facility Name
Manchester Royal Infirmary
City
Manchester
Country
United Kingdom
Facility Name
Queen Alexandra Hospital
City
Portsmouth
Country
United Kingdom
Facility Name
Royal Berkshire Hospital
City
Reading
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
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Dankiewicz J, Cronberg T, Lilja G, Jakobsen JC, Levin H, Ullen S, Rylander C, Wise MP, Oddo M, Cariou A, Belohlavek J, Hovdenes J, Saxena M, Kirkegaard H, Young PJ, Pelosi P, Storm C, Taccone FS, Joannidis M, Callaway C, Eastwood GM, Morgan MPG, Nordberg P, Erlinge D, Nichol AD, Chew MS, Hollenberg J, Thomas M, Bewley J, Sweet K, Grejs AM, Christensen S, Haenggi M, Levis A, Lundin A, During J, Schmidbauer S, Keeble TR, Karamasis GV, Schrag C, Faessler E, Smid O, Otahal M, Maggiorini M, Wendel Garcia PD, Jaubert P, Cole JM, Solar M, Borgquist O, Leithner C, Abed-Maillard S, Navarra L, Annborn M, Unden J, Brunetti I, Awad A, McGuigan P, Bjorkholt Olsen R, Cassina T, Vignon P, Langeland H, Lange T, Friberg H, Nielsen N; TTM2 Trial Investigators. Hypothermia versus Normothermia after Out-of-Hospital Cardiac Arrest. N Engl J Med. 2021 Jun 17;384(24):2283-2294. doi: 10.1056/NEJMoa2100591.
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Links:
URL
http://ttm2trial.org
Description
Trial official webpage

Learn more about this trial

Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest

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