Table 4.
Ongoing clinical trials for evaluating the possible role of therapeutic hypothermia in stroke and TBI*.
| Study title | Design | Intervention | Target enrollment |
|---|---|---|---|
| Intravenous thrombolysis plus hypothermia for acute treatment of ischemic stroke | Phase I, randomized, case–control | TH + t-PA | 130 |
| The intravascular cooling in the treatment of stroke 2/3 trial | Phase II/III, randomized, case–control | TH + t-PA | 400 |
| Mild hypothermia in acute ischemic stroke | Phase II, randomized, case–control | Mild TH | 36 |
| Caffeinol hypothermia protocol | Phase I/II, non-randomized, case–control | TH + caffeinol | 30 |
| Hypothermia in children after trauma | Phase II, randomized, case–control | Moderate TH | 340 |
| Hypothermia in traumatic brain injury in children (HiTBIC) | Phase II/III, randomized, case–control | TH | 50 |
| The prophylactic hypothermia trial to lessen traumatic brain injury | Phase III, randomized, case–control | TH | 512 |
| Discrete hypothermia in the management of traumatic brain injury | Phase III, randomized, case–control | TH | 25 |
| Mild hypothermia and supplemental magnesium sulfate infusion in severe traumatic brain injury (TBI) subjects | Phase II, randomized, case–control | TH + magnesium sulfate | 105 |
| Hypothermia in children after trauma | Phase III, randomized, case–control | TH | 340 |
| Therapeutic hypothermia for severe traumatic brain injury in Japan | Phase III, randomized, case–control | Mild TH | 300 |
*Data adapted from www.clinicaltrials.gov