Glycerol and dextran combined in the therapy of acute stroke. A placebo-controlled, double-blind trial with a planned interim analysis.
Author(s) -
Anja Frei,
C Cottier,
P Wunderlich,
Edward N. Ludin
Publication year - 1987
Publication title -
stroke
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.397
H-Index - 319
eISSN - 1524-4628
pISSN - 0039-2499
DOI - 10.1161/01.str.18.2.373
Subject(s) - medicine , placebo , interim analysis , interim , clinical trial , glycerol , anesthesia , stroke (engine) , acute stroke , surgery , mechanical engineering , chemistry , alternative medicine , archaeology , organic chemistry , pathology , tissue plasminogen activator , engineering , history
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.
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