Table 1.
Demographics and baseline characteristics of the intention-to-treat patients.
| Normothermia (n = 146) | Hypothermia (n = 156) | |
|---|---|---|
| Sex | ||
| Male | 112 (76·71%) | 127 (81·41%) |
| Female | 34 (23·28%) | 29 (18·59%) |
| Age (years) | 49·12 (12·82) | 44·72 (13·05) |
| Time from injury (hours) | 2·50 (1·27, 4·00) | 2 00 (1·15, 3·12) |
| Causes of TBI | ||
| Traffic incidents | 91 (62·33%) | 93 (59·61%) |
| Falls | 36 (24·66%) | 38 (24·36%) |
| Violence | 2 (1·37%) | 5 (3·21%) |
| Other causes | 17 (11·64%) | 20 (12·82%) |
| GCS | 6 (5, 7) | 6 (4, 7) |
| Temperature at randomization (°C) | 36·82 (0·60) | 36·79 (0·66) |
| SBP (mm Hg) | 139·10 (24·02) | 136·54 (23·01) |
| HR (Beats per minute) | 86·93 (21·28) | 86·03 (20·40) |
| Initial ICP (mm Hg) | 36·75 (10·40) | 36·15 (9·62) |
| Pupillary response | ||
| Both reacting | 77 (53·11%) | 86 (55·13%) |
| One reacting | 19 (13·10%) | 26 (16·67%) |
| Neither reacting | 49 (33·79%) | 44 (28·20%) |
| CT feature | ||
| Intracranial hematoma | 143 (97·95%) | 152 (97·44%) |
| Midline shift>5mm | 55 (37·67%) | 55 (35·26%) |
| Diffuse brain swelling | 35 (23·97%) | 43 (27·56%) |
| Surgery | ||
| Hematoma removal | 134 (91·78%) | 144 (92·31%) |
| Decompressive craniectomy | 104 (71·23%) | 106 (67·95%) |
| Laboratory findings | ||
| Alanine transaminase (U/L) | 27·50 (17·00, 43·75) | 28·00 (19·00, 38·00) |
| Aspartate aminotransferase (U/L) | 38·50 (26·25, 50·68) | 38·50 (29·00, 55·25) |
| Creatinine (μmol/L) | 65·00 (54·00, 76·00) | 64·00 (52·08, 80·00) |
| Blood urea nitrogen (mmol/L) | 5·10 (4·17, 6·70) | 5·30 (4·30, 6·55) |
| Ca2+ (mmol/L) | 1·85 (1·05, 2·08) | 1·89 (1·04, 2·08) |
| Cl− (mmol/L) | 105·23 (5·38) | 106·21 (6·87) |
| Na+ (mmol/L) | 140·25 (138·00, 143·00) | 140·30 (138·00, 143·10) |
| K+ (mmol/L) | 3·67 (0·60) | 3·68 (0·58) |
| pH | 7·39 (0·07) | 7·39 (0·07) |
| PaO2 (mm Hg) | 159·44 (89·35) | 160·35 (77·54) |
| PaCO2 (mm Hg) | 36·49 (8·07) | 36·99 (7·81) |
| Buffer excess (mmol/L) | −2·25 (3·91) | −2·55 (3·54) |
| Glucose (mmol/L) | 9·31 (7·78, 10·70) | 9·00 (7·70, 11·29) |
| White blood cells (10^9/L) | 13·90 (10·83, 19·03) | 14·50 (10·23, 19·34) |
| Hemoglobin (g/L) | 119·00 (97·25, 139·75) | 122·00 (97·00, 142·00) |
| Blood platelet (10^9/L) | 162·58 (70·56) | 168·03 (81·21) |
Data were represented as mean (SD), number (%) or median (IQR). TBI=traumatic brain injury. GCS=Glasgow coma scale. SBP=systolic blood pressure. HR=heart rate. ICP=intracranial pressure. CT=computerized tomography. Initial ICP refers to the ICP value firstly measured pre-operation.