Antifibrinolytic Treatment in Subarachnoid Hemorrhage
- 16 August 1984
- journal article
- clinical trial
- Published by Massachusetts Medical Society in New England Journal of Medicine
- Vol. 311 (7) , 432-437
- https://doi.org/10.1056/nejm198408163110703
Abstract
We enrolled 479 patients with subarachnoid hemorrhage in a multicenter, randomized, double-blind, placebo-controlled trial to determine whether treatment with the antifibrinolytic agent tranexamic acid improves outcome by preventing rebleeding. At three months there was no statistical difference between the outcomes in the tranexamic acid group and the control group. Of the 173 patients who died, 84 had received tranexamic acid and 89 placebo (95 per cent confidence interval for the difference in mortality rate, -6 to 11 per cent). Similarly, when analysis was restricted to patients with an angiographically demonstrated aneurysm, there was no significant difference between the groups. This absence of effect was not due to a lack of antifibrinolytic action, since the rate of rebleeding was reduced from 24 per cent in the control group to 9 per cent in the tranexamic acid-treated group (chi-square = 18.07, P<0.001), but resulted from a concurrent increase in the incidence of ischemic complications (15 per cent in the control group and 24 per cent in the tranexamic acid group; chi-square = 8.07, P<0.01). We conclude that until some method can be found to minimize ischemic complications, tranexamic acid is of no benefit in patients with subarachnoid hemorrhage. (N Engl J Med 1984; 311:432–7.)Keywords
This publication has 20 references indexed in Scilit:
- Explanatory and pragmatic attitudes in therapeutical trialsPublished by Elsevier ,2004
- Cerebral Arterial Spasm – A Controlled Trial of Nimodipine in Patients with Subarachnoid HemorrhageNew England Journal of Medicine, 1983
- Antifibrinolytic treatment in subarachnoid haemorrhage: Present stateActa Neurochirurgica, 1982
- Do antifibrinolytic agents prevent rebleeding after rupture of a cerebral aneurysm? A reviewClinical Neurology and Neurosurgery, 1980
- Ruptured intracranial aneurysmsJournal of Neurosurgery, 1977
- ASSESSMENT OF OUTCOME AFTER SEVERE BRAIN DAMAGE: A Practical ScalePublished by Elsevier ,1975
- FIBRINOLYSIS AND SUBARACHNOID HAEMORRHAGE. INHIBITORY EFFECT OF TRANEXAMIC ACIDA Clinical StudyActa Neurologica Scandinavica, 1972
- Antifibrinolytic Therapy for Intracranial AneurysmsJournal of Neurosurgery, 1968
- Fibrinolysis in subarachnoid haemorrhagePostgraduate Medical Journal, 1967
- An Experimental Approach to the Problem of Cerebral AneurysmJournal of Neurosurgery, 1964