Lascarrou 2019.

Study characteristics
Methods	Study type: RCT, pragmatic Aim of the study: efficacy Participating sites: 25 community and university hospitals in France Language: English
Participants	Number randomised: 287 (intervention); 297 (control) Patient population: cardiac arrest with non‐shockable rhythm due to any cause Inclusion criteria: aged ≥ 18 years, coma at ICU admission Exclusion criteria: no‐flow time > 10 minutes, low flow‐time > 60 minutes, major haemodynamic instability, time from cardiac arrest to screening > 300 minutes, moribund condition, Child‐Pugh Class C cirrhosis of the liver, pregnancy or breast‐feeding, under guardianship, inmate at a correctional facility, previous inclusion in another RCT involving people with cardiac arrest in which the neurological outcome at 90 days was assessed as the primary endpoint, lack of health insurance, decision by next of kin not to participate Median age: 67.1 (IQR 56.9–76.3) years (intervention); 67.2 (57.8–76.1) years (control) Women: 36% Cardiac arrest location: out‐of‐hospital and in‐hospital; out‐of‐hospital cardiac arrest: 73% Cause of cardiac arrest: any 27% Primary cardiac rhythm: asystole 78% pulseless electrical activity 12% Witnessed cardiac arrest: 94% Bystander CPR: 70% Timing (minutes): Cardiac arrest to randomisation (median): 232.5 (IQR 178–276) (intervention); 219.0 (IQR 170–266) (control) Low‐flow time (median): 15 (IQR 10–25) (intervention); 18.0 (IQR 10–26) (control) No‐flow time (median): 2 (IQR 0–5) (intervention); 1.0 (IQR 0–5) (control) ROSC to randomisation (extrapolated): 215 (intervention); 200 (control) Temperature on admission/at start of cooling: 35.5 °C (intervention); 35.4 °C (control) Subgroups reported: location: out‐of‐hospital vs in‐hospital cardiac arrest cause of cardiac arrest: cardiac vs non‐cardiac time to ROSC: < 15 minutes, > 15 minutes
Interventions	Number randomised: 287 (intervention); 297 (control) Prehospital cooling: no Description of intervention: participants allocated at random to moderate therapeutic hypothermia had hypothermia (33 °C) induced then maintained for 24 hours. Slow rewarming to 37 °C with a target rewarming rate 0.25–0.5 °C/hour was then performed, and target temperature of 37 °C was maintained for 24 hours. Cooling methods included active internal cooling using a specific device, active external cooling using a specific device, and active external cooling without a specific device. Infusion of cold fluid (4 °C) is recommended to expedite achievement of the target temperature Duration (hours) of TTM: 24 Was intervention initiated within 2 hours of ROSC? no Was target temperature reached within 4 hours of ROSC? no Co‐interventions? no Was rewarming controlled? yes Rewarming rate (per protocol): 0.25–0.5 °C/hours Timing (minutes): ROSC to randomisation: 232 (intervention); 219 (control) randomisation to start of TTM: 16 randomisation to target temperature: 317 start of TTM to target temperature: 301
Outcomes	Good neurological outcome (CPC on day 90) Death (day 90) Duration of mechanical ventilation Length of stay in ICU Survival to ICU discharge Duration of mechanical ventilation Length of stay in ICU Survival to hospital discharge Adverse events
Control group treatment	Participants had their body temperature maintained at 36.5–37.5 °C for 48 hours. Participants whose temperature was below 36.5 °C at randomisation were warmed at a target rate 0.25–0.5 °C
Funding source	Supported by independent research grants from the French Ministry of Health, the non‐profit healthcare institution Centre Hospitalier Départemental Vendée and the Laerdal Foundation.
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