Table 1.
Randomized Clinical Trials with Positive Results in TBI Patients, 1990–2012
| Therapy | N | Type | Results | References |
|---|---|---|---|---|
| Pharmacological therapies | ||||
| Nimodipine | 123 TBI w SAH |
RCT, multi | Significantly fewer unfavorable GOS scores at 6 months in nimodipine group | Harders et al.28 |
| Progesterone | 159 sev TBI | RCT | Significantly more favorable outcomes (GOS & FIM) and lower mortality in progesterone-treated pts 3 and 6 months post-TBI | Xiao et al.30 |
| Amantadine | 184 sev TBI | RCT, multi | Significantly faster rate of functional recovery (DRS) 4 wks post-TBI in amantadine-treated pts | Giacino et al.27 |
| Phenytoin | 404 sev TBI | RCT, single | Significantly fewer seizures in phenytoin-treated pts 1-7 days post-TBI | Temkin et al.26 |
| Surgical/Management therapies | ||||
| Hypothermia | 215 sev TBI | RCT, multi | Significantly lower ICP and more favorable GOS in sev TBI pts with 5 days vs. 2 days of hypothermia | Jiang et al.20 |
| 47 sev TBI | RCT, single | Significant reduction in number of seizures in hypothermic patients | Clifton et al.23 | |
| 396 sev TBI | RCT, single | Significantly lower mortality and more favorable outcome in hypothermia group | Zhi et al.21 | |
| 82 sev TBI | RCT, single | hypothermia hastened neurological recovery; trend toward improved outcome | Marion et al.24 | |
| Craniectomy | 486 sev TBI | RCT, multi | Significantly more favorable GOS at 6 months in pts with larger (15x15 cm) vs. smaller (6x8 cm) craniectomy | Jiang et al.156 |
| Craniectomy | 408 sev TBI | RCT, multi | Significantly lower mortality in decompressive craniectomy group | Hutchinson et al.157 |
| CBF targeted therapy | 189 sev TBI | RCT, single | Jugular venous desaturation significantly lower in CBF- vs. ICP-targeted therapy | Robertson et al.18 |
| Hyperbaric O2 | 168 sev TBI | RCT, single | Mortality rate was significantly lower in pts treated with hyperbaric O2 | Rockswold et al.19 |
CBF, cerebral blood flow; DRS, disability rating scale; FIM, functional independence measure; GOS, Glasgow Outcome Scale; multi, multi-center RCT; pts, patients; RCT, randomized clinical trial; SAH, subarachnoid hemorrhage; single, single-center RCT; sev, severe; TBI, traumatic brain injury.