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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	10 April 2023
Main ID:	NCT02908308
Date of registration:	16/09/2016
Prospective Registration:	Yes
Primary sponsor:	Helsingborgs Hospital
Public title:	Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest TTM-2
Scientific title:	Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest (TTM2) - A Randomised Clinical Trial
Date of first enrolment:	November 18, 2017
Target sample size:	1900
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02908308
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor).
Phase:	N/A

Countries of recruitment
Australia	Austria	Belgium	Czech Republic	Czechia	Denmark	France	Germany
Italy	Luxembourg	Netherlands	New Zealand	Norway	Sweden	Switzerland	United Kingdom
United States

Contacts

Name:	Paul Young, MD
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Affiliation:	Wellington Regional Hospital

Name:	Matt P Wise, MD, PhD
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Affiliation:	University Hospital of Wales, Cardiff, UK

Name:	Hans Kirkegaard, MD,PhD
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Affiliation:	Aarhus University Hospital

Name:	Christian Storm, MD, PhD
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Affiliation:	Charité-University Medicine (Berlin, Germany)

Name:	Michael Ioannidis, MD, PhD
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Affiliation:	Innsbruck University Hospital

Name:	Hans Friberg, MD, PhD
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Affiliation:	Lund University Hospital, Lund, Sweden

Name:	Tobias Cronberg, MD, PhD
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Affiliation:	Lund University Hospital, Lund, Sweden

Name:	Per Nordberg, MD, PhD
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Affiliation:	Södersjukhuset, Stockholm

Name:	Clifton W Callaway, MD, PhD
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Affiliation:	University of Pittsburgh, Pittsburgh, USA

Name:	Jan Belholavek, MD, PhD
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Affiliation:	Prague University Hospital

Name:	Manoj Saxena, MD, PhD
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Affiliation:	The George Institute for Global Health (Sydney, Australia)

Name:	Mauro Oddo, MD, PhD
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Affiliation:	Université de Lausanne, Lausanne, Switzerland

Name:	Alain Cariou, MD, PhD
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Affiliation:	Université Paris Descartes, France

Name:	Alistair Nichol, MD, PhD
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Affiliation:	Department of Anaesthesia and Intensive Care Medicine, St Vincent's University Hospital

Name:	Niklas Nielsen, MD, PhD
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Affiliation:	Helsingborgs lasarett, Region Skåne, Sweden

Name:	Paolo Pelosi, MD, PhD
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Affiliation:	San Martino University Hospital, Genoa

Name:	Josef Dankiewicz, MD, PhD
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Affiliation:	Skåne University Hospital Lund

Name:	Fabio Taccone, MD, PhD
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Affiliation:	Hopital Erasme, Brussles, Belgium

Name:	David Erlinge, MD, PhD
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Affiliation:	Lund University Hospital, Lund, Sweden

Name:	Jan Hovdenes, MD, PhD
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Affiliation:	Oslo University Hospital, Oslo, Norway

Name:	Christian Rylander, MD, PhD
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Affiliation:	Sahlgrenska University Hospital, Gothenburg, Sweden

Key inclusion & exclusion criteria

Inclusion Criteria:

- Out-of-hospital cardiac arrest

- Presumed cardiac cause of cardiac arrest

- Unconscious with a FOUR-score
- 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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Out-of-hospital Cardiac Arrest

Intervention(s)

Procedure: Standard care with early treatment of fever

Procedure: Targeted temperature management to 33°C

Primary Outcome(s)

Mortality [Time Frame: 180 days]

Secondary Outcome(s)

Days alive outside hospital [Time Frame: 180 days.]

Poor functional outcome [Time Frame: 180 days]

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

Quality of Life [Time Frame: 180 days]

Secondary ID(s)

TTM-2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Clinical Trials Sweden, Forum South

Lund University

Region Skåne - Skånevård SUND

Copenhagen Trial Unit, Center for Clinical Intervention Research

Integrated Biobank of Luxembourg

Ethics review

Results

Results available:
Date Posted:
Date Completed:
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