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Tt2 compendium trial#

70% cooled with external devices and 30% with intravascular devices.Rewarming began after 28 hours (increase temperature by no more than 0.3☌ per hour until 40 hours).A feedback-controlled system used to maintain target temperature (bladder temperature probe).Rapid cooling achieved by cold fluids and physical cooling devices (surface or intravascular devices).Hypothermia group: target temperature 33C.Defined as SBP 30 minutes or evidence of end-organ hypoperfusion.Baseline characteristics between groups (Hypothermia vs Normothermia).1850 analysed for survival (11 lost to follow-up).930 in Hypothermia arm, 931 in Normothermia arm.1861 analysed as intention to treat (39 withdrew consent).Unconscious: as defined by the FOUR score motor response 180 minutes since ROSC, non-cardiac cause for arrest, not unconscious, limitations to care in place.Sustained ROSC: >20 minutes of circulation without need for chest compressions.Out-of-hospital cardiac arrest of presumed cardiac or unknown cause.

Last data collection: 6-month follow-up completed mid 2020 with 24 month follow-up ongoing.Active recruiting through 2018 to early 2020 Dates of randomisation: pilot phase began late 2017.Highest recruiting countries: Sweden, UK, Switzerland, France, Czech Republic.Number of countries: 14 countries, 61 institutions.This was increased to 1900 to account for loss to follow-up Power Calculation: A total of 1862 participants gave a power of 90% (alpha 0.05, NNT 13.3) to detect an absolute risk reduction of 7.5% in mortality (assuming 55% mortality).MRS was performed via a structured interview with interviewers receiving formal training.Where possible the patient and a proxy were used to obtain information Outcome assessment was by face-to-face interview (72%) or telephone interview (particularly used when the COVID-19 pandemic began).Duplicate manuscripts were written for each scenario before randomisation was revealed.Non blinded clinicians, however assessors of prognosis, participants, outcome assessors, statisticians, data managers blinded.Outcomes assessed at 30 days, 6 months, 24 months (ongoing).Pre-specified secondary outcomes (neurological outcome and health related quality of life) and subgroup analyses (sex, age, time to ROSC, initial rhythm and whether shock present on admission).Web-based allocation using permuted blocks of varying sizes (stratified by site + TAME randomisation) in 1:1 ratio.Randomisation occurred in the emergency department.

Tt2 compendium trial#

Co-enrolment with the TAME trial (Targeted Therapeutic Mild Hypercapnia).

International, multicentre, parallel group trial.

Fever is associated with worse outcomes.

avoidance of fever (> 37.7☌) for at least 72 h after ROSC in patients who remain in coma.

maintaining a target temperature at a constant value between 32 and 36☌ for at least 24 h.

The European Resuscitation Council released new guidelines in March 2021.

The HYPERION trial (n=584) showed that in patients with coma following a non-shockable cardiac arrest, the use of moderate hypothermia improved favourable neurological outcome at 90 days compared with targeted normothermia.

They reported no significant difference in all-cause mortality

36☌ in patients with an out-of-hospital cardiac arrest from a presumed cardiac cause.

The TTM (2013) study (n=950) compared a targeted temperature of 33☌ vs.

A number of patients in the control group developed fever and it was therefore unclear if the reported benefits were from hypothermia or the avoidance of fever However, small sample sizes and other methodological flaws meant the evidence was of low certainty.

The HACA trial (n=137) and Bernard trials (n=77) published in NEJM in 2002 reported that therapeutic hypothermia following a VF arrest improved favourable neurological outcome.

There have been several randomised trials investigating temperature management following cardiac arrest.

In patients who are unconscious following out-of-hospital cardiac arrest, does targeted hypothermia compared with targeted normothermia, impact all-cause mortality?.Hypothermia versus Normothermia after Out-of-Hospital Cardiac Arrestĭankiewicz J for the TTM2 Trial Investigators.