Disappointing results from this study of hypothermic head injury treatment
(although the hypothermia was initiated in hospital after up to 6 hours).
The New England Journal of Medicine -- February 22, 2001 -- Vol. 344, No. 8
Lack of Effect of Induction of Hypothermia after Acute Brain Injury
Guy L. Clifton, Emmy R. Miller, Sung C. Choi, Harvey S. Levin, Stephen
McCauley, Kenneth R. Smith, Jr., J. Paul Muizelaar, Franklin C. Wagner, Jr.,
Donald W. Marion, Thomas G. Luerssen, Randall M. Chesnut, Michael Schwartz
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Abstract
Background. Induction of hypothermia in patients with brain injury was shown
to improve outcomes in small clinical studies, but the results were not
definitive. To study this issue, we conducted a multicenter trial comparing
the effects of hypothermia with those of normothermia in patients with acute
brain injury.
Methods. The study subjects were 392 patients 16 to 65 years of age with
coma after sustaining closed head injuries who were randomly assigned to be
treated with hypothermia (body temperature, 33°C), which was initiated
within 6 hours after injury and maintained for 48 hours by means of surface
cooling, or normothermia. All patients otherwise received standard
treatment. The primary outcome measure was functional status six months
after the injury.
Results. The mean age of the patients and the type and severity of injury in
the two treatment groups were similar. The mean (±SD) time from injury to
randomization was 4.3±1.1 hours in the hypothermia group and 4.1±1.2 hours
in the normothermia group, and the mean time from injury to the achievement
of the target temperature of 33°C in the hypothermia group was 8.4±3.0
hours. The outcome was poor (defined as severe disability, a vegetative
state, or death) in 57 percent of the patients in both groups. Mortality was
28 percent in the hypothermia group and 27 percent in the normothermia group
(P=0.79). The patients in the hypothermia group had more hospital days with
complications than the patients in the normothermia group. Fewer patients in
the hypothermia group had high intracranial pressure than in the
normothermia group.
Conclusions. Treatment with hypothermia, with the body temperature reaching
33°C within eight hours after injury, is not effective in improving outcomes
in patients with severe brain injury. (N Engl J Med 2001;344:556-63.)
Robbie Coull
email: [log in to unmask] website: http://www.coull.net
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