Abstract | OBJECT: METHODS: The National Acute Brain Injury Study: Hypothermia I (NABIS:H I) was a randomized multicenter clinical trial of 392 patients with severe brain injury treated using normothermia or hypothermia for 48 hours with patients reaching 33°C at 8.4 ± 3 hours after injury. The National Acute Brain Injury Study: Hypothermia II (NABIS:H II) was a randomized, multicenter clinical trial of 97 patients with severe brain injury treated with normothermia or hypothermia for 48 hours with patients reaching 35°C within 2.6 ± 1.2 hours and 33°C within 4.4 ± 1.5 hours of injury. Entry and exclusion criteria, management, and outcome measures in the 2 trials were similar. RESULTS: In NABIS:H II among the patients with evacuated intracranial hematomas, outcome was poor (severe disability, vegetative state, or death) in 5 of 15 patients in the hypothermia group and in 9 of 13 patients in the normothermia group (relative risk 0.44, 95% CI 0.22-0.88; p = 0.02). All patients randomized to hypothermia reached 35°C within 1.5 hours after surgery start and 33°C within 5.55 hours. Applying these criteria to NABIS:H I, 31 of 54 hypothermia-treated patients reached a temperature of 35°C or lower within 1.5 hours after surgery start time, and the remaining 23 patients reached 35°C at later time points. Outcome was poor in 14 (45%) of 31 patients reaching 35°C within 1.5 hours of surgery, in 14 (61%) of 23 patients reaching 35°C more than 1.5 hours of surgery, and in 35 (60%) of 58 patients in the normothermia group (relative risk 0.74, 95%, CI 0.49-1.13; p = 0.16). A meta-analysis of 46 patients with hematomas in both trials who reached 35°C within 1.5 hours of surgery start showed a significantly reduced rate of poor outcomes (41%) compared with 94 patients treated with hypothermia who did not reach 35°C within that time and patients treated at normothermia (62%, p = 0.009). CONCLUSIONS:
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Authors | Guy L Clifton, Christopher S Coffey, Sierra Fourwinds, David Zygun, Alex Valadka, Kenneth R Smith Jr, Melisa L Frisby, Richard D Bucholz, Elisabeth A Wilde, Harvey S Levin, David O Okonkwo |
Journal | Journal of neurosurgery
(J Neurosurg)
Vol. 117
Issue 4
Pg. 714-20
(Oct 2012)
ISSN: 1933-0693 [Electronic] United States |
PMID | 22839656
(Publication Type: Journal Article, Research Support, N.I.H., Extramural)
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Topics |
- Adolescent
- Adult
- Aged
- Blood Pressure
(physiology)
- Body Temperature
(physiology)
- Craniotomy
(methods)
- Glasgow Coma Scale
- Humans
- Hypothermia, Induced
(methods)
- Intracranial Hemorrhage, Traumatic
(physiopathology, surgery)
- Intracranial Pressure
(physiology)
- Middle Aged
- Randomized Controlled Trials as Topic
- Reperfusion Injury
(prevention & control)
- Suction
- Time Factors
- Treatment Outcome
- Young Adult
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