Table 5.
Deviations from the Study Protocol and Complications
| Variable | n (%) |
|---|---|
| Deviations from the study protocol | |
| Therapeutic hypothermia group | 98 |
| Patients who could not be cooled to | |
| 35.5°C within 6 h of TBI onset | 35 (36) |
| 34.0°C within 6 h of TBI onset | 61 (62) |
| Unexpected hypotension before temperature management | 5 (5) |
| Unexpected hypoxia before temperature management | 1 (1) |
| Untreatable bleeding after cooling | 2 (2) |
| Continuous infusion of barbiturate or propofol | 3 (3) |
| Fever control group | 50 |
| Found to be >70 years old after randomization | 1 (2) |
| Unexpected hypotension after temperature management | 1 (2) |
| Uncontrollable ICP and using hypothermia treatment | 4 (8) |
| Complications | |
| Therapeutic hypothermia group | 98 |
| Thrombocytopaenia | 6 (6) |
| Sepsis | 5 (5) |
| Severe pneumonia | 3 (3) |
| Coagulopathy | 2 (2) |
| Arrythmia | 1 (1) |
| Fever control group | 50 |
| Severe pneumonia | 1 (2) |
TBI, traumatic brain injury; ICP, intracranial pressure