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 journalArticle

418 Citations (Scopus)

Abstract

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
Volume10
Issue number3
DOIs
StatePublished - Jan 1 1993

Fingerprint

Hypothermia
Brain Injuries
Chi-Square Distribution
Glasgow Coma Scale
Nonparametric Statistics
Glasgow Outcome Scale
Rewarming
Nonpenetrating Wounds
Temperature
Wounds and Injuries
Craniocerebral Trauma
Morphine
Nervous System
Sepsis
Seizures
Maintenance
Muscles
Incidence

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

Clifton, G. L., Allen, S., Barrodale, P., Plenger, P., Berry, J., Koch, S., ... Choi, S. C. (1993). A Phase II Study of Moderate Hypothermia in Severe Brain Injury. Journal of Neurotrauma, 10(3), 263-271. https://doi.org/10.1089/neu.1993.10.263

A Phase II Study of Moderate Hypothermia in Severe Brain Injury. / Clifton, Guy L.; Allen, Steven; Barrodale, Patricia; Plenger, Patrick; Berry, James; Koch, Stephen; Fletcher, Jack; Hayes, Ronald L.; Choi, Sung C.

In: Journal of Neurotrauma, Vol. 10, No. 3, 01.01.1993, p. 263-271.

Research output: Contribution to journalArticle

Clifton, GL, Allen, S, Barrodale, P, Plenger, P, Berry, J, Koch, S, Fletcher, J, Hayes, RL & Choi, SC 1993, 'A Phase II Study of Moderate Hypothermia in Severe Brain Injury', Journal of Neurotrauma, vol. 10, no. 3, pp. 263-271. https://doi.org/10.1089/neu.1993.10.263
Clifton GL, Allen S, Barrodale P, Plenger P, Berry J, Koch S et al. A Phase II Study of Moderate Hypothermia in Severe Brain Injury. Journal of Neurotrauma. 1993 Jan 1;10(3):263-271. https://doi.org/10.1089/neu.1993.10.263
Clifton, Guy L. ; Allen, Steven ; Barrodale, Patricia ; Plenger, Patrick ; Berry, James ; Koch, Stephen ; Fletcher, Jack ; Hayes, Ronald L. ; Choi, Sung C. / A Phase II Study of Moderate Hypothermia in Severe Brain Injury. In: Journal of Neurotrauma. 1993 ; Vol. 10, No. 3. pp. 263-271.
@article{41667b20cf754948a8be36e227fc29bb,
title = "A Phase II Study of Moderate Hypothermia in Severe Brain Injury",
abstract = "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.",
author = "Clifton, {Guy L.} and Steven Allen and Patricia Barrodale and Patrick Plenger and James Berry and Stephen Koch and Jack Fletcher and Hayes, {Ronald L.} and Choi, {Sung C.}",
year = "1993",
month = "1",
day = "1",
doi = "10.1089/neu.1993.10.263",
language = "English (US)",
volume = "10",
pages = "263--271",
journal = "Journal of Neurotrauma",
issn = "0897-7151",
publisher = "Mary Ann Liebert Inc.",
number = "3",

}

TY - JOUR

T1 - A Phase II Study of Moderate Hypothermia in Severe Brain Injury

AU - Clifton, Guy L.

AU - Allen, Steven

AU - Barrodale, Patricia

AU - Plenger, Patrick

AU - Berry, James

AU - Koch, Stephen

AU - Fletcher, Jack

AU - Hayes, Ronald L.

AU - Choi, Sung C.

PY - 1993/1/1

Y1 - 1993/1/1

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=0027440467&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0027440467&partnerID=8YFLogxK

U2 - 10.1089/neu.1993.10.263

DO - 10.1089/neu.1993.10.263

M3 - Article

C2 - 8258839

AN - SCOPUS:0027440467

VL - 10

SP - 263

EP - 271

JO - Journal of Neurotrauma

JF - Journal of Neurotrauma

SN - 0897-7151

IS - 3

ER -