A negative trial that was published. The
Extended Glasgow Outcome Scale may be widely used and accepted but it still has no objective measurement except for the death answer.
Does this invalidate this research?
With NO stroke leadership or strategy we will never know that answer.
Wright DW,
Yeatts SD,
Silbergleit R,
Palesch YY,
Hertzberg VS,
Frankel M,
Goldstein FC,
Caveney AF,
Howlett-Smith H,
Bengelink EM,
Manley GT,
Merck LH,
Janis LS,
Barsan WG;
NETT Investigators.
Abstract
BACKGROUND:
Traumatic
brain injury (TBI) is a major cause of death and disability worldwide.
Progesterone has been shown to improve neurologic outcome in multiple
experimental models and two early-phase trials involving patients with
TBI.
METHODS:
We
conducted a double-blind, multicenter clinical trial in which patients
with severe, moderate-to-severe, or moderate acute TBI (Glasgow Coma
Scale score of 4 to 12, on a scale from 3 to 15, with lower scores
indicating a lower level of consciousness) were randomly assigned to
intravenous progesterone or placebo, with the study treatment initiated
within 4 hours after injury and administered for a total of 96 hours.
Efficacy was defined as an increase of 10 percentage points in the
proportion of patients with a favorable outcome, as determined with the
use of the stratified dichotomy of the Extended Glasgow Outcome Scale
score at 6 months after injury. Secondary outcomes included mortality
and the Disability Rating Scale score.
RESULTS:
A
total of 882 of the planned sample of 1140 patients underwent
randomization before the trial was stopped for futility with respect to
the primary outcome. The study groups were similar with regard to
baseline characteristics; the median age of the patients was 35 years,
73.7% were men, 15.2% were black, and the mean Injury Severity Score was
24.4 (on a scale from 0 to 75, with higher scores indicating greater
severity). The most frequent mechanism of injury was a motor vehicle
accident. There was no significant difference between the progesterone
group and the placebo group in the proportion of patients with a
favorable outcome (relative benefit of progesterone, 0.95; 95%
confidence interval [CI], 0.85 to 1.06; P=0.35). Phlebitis or
thrombophlebitis was more frequent in the progesterone group than in the
placebo group (relative risk, 3.03; CI, 1.96 to 4.66). There were no
significant differences in the other prespecified safety outcomes.
CONCLUSIONS:
This
clinical trial did not show a benefit of progesterone over placebo in
the improvement of outcomes in patients with acute TBI. (Funded by the
National Institute of Neurological Disorders and Stroke and others;
PROTECT III ClinicalTrials.gov number,
NCT00822900.).
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