TREATMENT OF ACUTE CEREBRAL-HEMORRHAGE WITH INTRAVENOUS GLYCEROL - A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED TRIAL

Background and Purpose: Hitherto, treatment of acute cerebral hemorrhage with intravenous glycerol has not been evaluated in rigorous clinical studies with sufficient patient numbers. Methods: We undertook a double-blind, stratified and randomized, placebo-controlled clinical trial. Only patients with a first stroke admitted to the hospital within 24 hours after onset of symptoms were recruited, provided computed tomography confirmed hemorrhage and informed consent was obtained. After stratification into alert, semicoma, and coma subgroups using the Glasgow Coma Scale, 107 patients received active treatment (500 ml of 10% glycerol in saline by intravenous infusion over 4 hours on 6 consecutive days) and 109 were given corresponding saline treatment. Using a variety of objective scoring systems, patients were followed up for up to 6 months. Results: At follow-up, all measures of outcome in the treated and control groups were very similar. At 6 months, respective mortality rates were 37 of 107 and 33 of 109. Corresponding mean+/-SD improvements in Scandinavian Stroke Study Group scores were 8.35+/-16.9 versus 11.55+/-15.6 (long-term) and 0.64+/-7.3 versus 2.40+/-6.9 (prognostic), and improvements in the Barthel Index ratings were 10.72+/-24.7 versus 13.95+/-23.3, respectively. Glasgow Coma Scale score improvements in the survivors were 0.81+/-1.5 and 1.16+/-1.7 in the treated and control groups, respectively. Hemolysis (generally subclinical) was the only adverse effect of glycerol noted. Conclusions: In the absence of any clinically or statistically significant difference in outcome between the treated and control groups, this trial provides no justification for glycerol therapy following acute cerebral hemorrhage.