Cardiovascular Atlas
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TTM2

A randomized trial in 1900 adults who were in a coma after a cardiac arrest outside hospital, of presumed cardiac or unknown cause. One group was cooled to 33 degrees C and then rewarmed in a controlled way; the other was kept at a normal temperature, with the fever treated early. After 6 months, deaths were about the same: 50% with cooling and 48% with normothermia. Heart rhythm problems that affected circulation were more common with cooling (24% against 17%).

Also called TTM-2 · Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest

  • Study
  • In this atlas

Overview

Design
Randomized, parallel-group trial. Open-label with blinded assessment of outcomes (abstract); the registry lists masking as triple and its description says the clinical team was not blinded to allocation.
Phase
Not applicable
Enrolled
  • 1,900 participants (enrolled count) (Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest, retrieved )
Sponsor
Not recorded
Funder
Not recorded
Registry
  • NCT NCT02908308
Started
(actual) (Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest, retrieved )
Primary completion
(actual) (Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest, retrieved )
Completion
(actual) (Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest, retrieved )
Countries
United States, Australia, Austria, Belgium, Czechia, Denmark, France, Germany, Italy, New Zealand, Norway, Sweden, Switzerland, United Kingdom (Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest, retrieved )
Care setting
Not reported
Registry status
  • “COMPLETED” (U.S. National Library of Medicine (ClinicalTrials.gov), retrieved )

Technical summary

ClinicalTrials.gov NCT02908308: a randomized, parallel-group study, phase not applicable, with Helsingborgs Hospital as lead sponsor (no organization record is kept for it here), status completed, start 2017-11-18, primary completion 2022-06-30 and completion 2022-12-31 (all actual), enrollment 1900 (actual) and locations in 14 countries. The registry lists Luxembourg and the Netherlands under removed countries and they are not counted. It lists masking as triple, while its description says the care team was not blinded; the paper's abstract says open-label with blinded outcome assessment. The primary outcome in the registry is mortality over 180 days; the paper's is death from any cause at 6 months. The record holds no results. The numbers are on the claim.

Arms

  • Targeted hypothermia

    Intervention Temperature control after cardiac arrest

    Targeted temperature management to 33 degrees C followed by controlled rewarming (abstract); the registry says up to 28 hours. 925 patients were evaluated for the primary outcome.

  • Targeted normothermia with early treatment of fever

    Intervention Temperature control after cardiac arrest

    Standard care with early treatment of fever; the registry says active temperature control with a device is used if the patient's temperature reaches 37.8 degrees C or higher. 925 patients were evaluated for the primary outcome.

Findings

No findings are published for this study.

Record details

Record id
cardio:ttm2
Content hash
3cbda113eb68f0d13f5ae8b8eebbf0aa11d3bf44c75e7aa923094d6d2e8daa7c