Table 2.
Recent randomized clinical trials (RCTs) relating TTM on TBI
| 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 |
TBI traumatic brain injury, TH therapeutic hypothermia, NS not significant, Normo normothermia, NM not mentioned