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Table 2 Recent randomized clinical trials (RCTs) relating TTM on TBI

From: Targeted temperature management in traumatic brain injury

RCTs Age (years old) No. of patients Type of TBI Control temperature Time interval of temperature control Rewarming speed Neurologic outcome Mortality Comments/references
NABIS:H 16–65 392 All, severe 33 °C vs 37 °C 48 h 0.5 °C/2 h 57 % poor outcome in each group, NS 28 % TH vs 27 % Normo, NS Clifton et al. [30]
Weak evidence of improved outcomes in patients who were initially hypothermic on admission
NABIS:H II 16–45 97 All, severe, 2.5 h after suffering TBI 33 °C vs 37 °C 48 h 0.5 °C/2 h 60 % TH 57 % Normo, NS 23 % TH vs 18 % Normo NS Clifton et al. [30]
Early-induced hypothermia proved significantly efficacious for surgically evacuated hematoma
B-HYPO 15–70 148 All 32-34 °C vs 35.5–37 °C >72 h and <1 °C/day Relative risk (RR) 1.24, 95 % confidence interval (CI) 0.62–2.48, p = 0.597, NS (RR 1.82, 95 % CI 0.82–4.03, p = 0.180) NS Maekawa et al. [33]
Clinical Trial gov. NCT00134472 UMIN 000000231
EUROTHERM 3235 −65 1800 Primary closed TBI with raised ICP >20 mmHg 32-35 °C vs Normo 48 h continued for as long as is necessary to reduce and maintain ICP <20 mmHg NM Andrews et al. [89]
LTH-1 18–65 300 All, GCS4-8 Longer TH (34–35 °C) for 5 days vs Normo (36–37 °C). 5 days <0.5 °C/4 h Lei et al. [62]
ClinicalTrials.gov Identifier: NCT01886222
HOPES 21–65 120 ASDH with Evacuated (GCSM <6) 33 °C vs 37 °C Preoperative induction 48 h 0.1 °C/h ClinicalTrials.gov NCT02064959 and UMIN 000014863
  1. TBI traumatic brain injury, TH therapeutic hypothermia, NS not significant, Normo normothermia, NM not mentioned