Glycerol and dextran combined in the therapy of acute stroke. A placebo-controlled, double-blind trial with a planned interim analysis.
The results of clinical trials investigating various therapies in acute ischemic stroke have been inconsistent. The effect of glycerol therapy and a combination therapy of glycerol and dextran was evaluated in a double-blind, placebo-controlled study. Repeated neurologic examinations (Day 0, Weeks 1, 6, 12, and 24) according to a modified Mathew score were performed on 62 patients. Statistical analysis showed no superiority of either treatment compared with placebo in acute ischemic stroke. A retrospective estimation of the Type II error of the study yielded approximately p = 0.25. A major side effect was hemolysis in 98% of patients treated with glycerol.
D000208:Acute Disease; D000368:Aged; D002561:Cerebrovascular Disorders / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology; D002986:Clinical Trials as Topic; D003911:Dextrans / Q000627:therapeutic use*; D004185:Disability Evaluation; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005990:Glycerol / Q000627:therapeutic use*; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D008297:Male; D008875:Middle Aged; D009420:Nervous System / Q000503:physiopathology; D011859:Radiography; D013924:Thrombophlebitis / Q000209:etiology
D003911:Dextrans; D004338:Drug Combinations; D006454:Hemoglobins; D005990:Glycerol