A Phase II Study of Moderate Hypothermia in Severe Brain Injury

Guy L. Clifton, Steven Allen, Patricia Barrodale, Patrick Plenger, James Berry, Stephen Koch, Jack Fletcher, Ronald L. Hayes, Sung C. Choi

Research output: Contribution to journalArticlepeer-review

454 Scopus citations


Forty-six patients with severe nonpenetrating brain injury [Glasgow Coma Scale (GCS) 4–7] were randomized to standard management at 37°C (n = 22) and to standard management with systemic hypothermia to 32 to 33°C (n = 24). The two groups were balanced in terms of age (Wilcoxon's rank sum test, p > 0.95), randomizing GCS (chi-square test, p = 0.54), and primary diagnosis. Cooling was begun within 6 h of injury by use of cooling blankets. Metocurine and morphine were given hourly during induction and maintenance of hypothermia. Rewarming was at a rate of 1°C per 4 h beginning 48 h after intravascular temperature had reached 33°C. Muscle relaxants and sedation were continued until core temperature reached 35°C. There were no cardiac or coagulopathy-related complications. Seizure incidence was lower in the hypothermia group (Fisher's exact text, p = 0.019). Sepsis was seen more commonly in the hypthermia group, but difference was not statistically significant (chi-square test). Mean Glasgow Outcome Scale (GOS) score at 3 months after injury showed an absolute increase of 16% (i.e., 36.4–52.2%) in the number of patients in the Good Recovery/Moderate Disability (GR/MD) category as compared with Severe Disability/ Vegetative/Dead (SD/V/D) (chi-square test, p > 0.287). Based on evidence of improved neurologic outcome with minimal toxicity, we believe that phase III testing of moderate systemic hypothermia in patients with severe head injury is warranted.

Original languageEnglish (US)
Pages (from-to)263-271
Number of pages9
JournalJournal of neurotrauma
Issue number3
StatePublished - 1993

ASJC Scopus subject areas

  • Clinical Neurology


Dive into the research topics of 'A Phase II Study of Moderate Hypothermia in Severe Brain Injury'. Together they form a unique fingerprint.

Cite this