(Stroke. 1999;30:484-488.)
© 1999 American Heart Association, Inc.
Original Contributions |
From Leyenburg Hospital, The Hague (S.F.T.M. d B), and Academic Medical Centre, Amsterdam (J.S), the Netherlands. A complete list of the members of the Cerebral Venous Sinus Thrombosis Study Group appears in the Appendix.
Correspondence to J. Stam, MD, Academic Medical Centre, PO Box 22700, 1100 DE Amsterdam, Netherlands. E-mail J.Stam{at}AMC.UVA.NL
Background and PurposeTreatment of cerebral sinus thrombosis with heparin is controversial. We conducted a double-blind, placebo-controlled multicenter trial to examine whether anticoagulant treatment improves outcome in patients with sinus thrombosis.
MethodsPatients were randomized between body weightadjusted subcutaneous nadroparin (180 antifactor Xa units/kg per 24 hours) and matching placebo for 3 weeks (double-blind part of trial), followed by 3 months of oral anticoagulants for patients allocated nadroparin (open part). Patients with cerebral hemorrhage caused by sinus thrombosis were also included.
ResultsSixty patients were enrolled, and none were lost to
follow-up. In 1 patient the diagnosis proved wrong after randomization.
After 3 weeks, 6 of 30 patients (20%) in the nadroparin group and 7 of
29 patients (24%) in the placebo group had a poor outcome, defined as
death or Barthel Index score of <15 (risk difference, -4%; 95% CI,
-25 to 17%; NS). After 12 weeks, 4 of 30 patients (13%) in the
nadroparin group and 6 of 29 (21%) in the placebo group had a poor
outcome, defined as death or Oxford Handicap Score of
3 (risk
difference, -7%; 95% CI, -26% to 12%; NS). There were no new
symptomatic cerebral hemorrhages. One patient in
the nadroparin group had a major gastrointestinal hemorrhage,
and 1 patient in the placebo group died from clinically suspected
pulmonary embolism.
ConclusionsPatients with cerebral sinus thrombosis treated with anticoagulants (low-molecular-weight heparin followed by oral anticoagulation) had a favorable outcome more often than controls, but the difference was not statistically significant. Anticoagulation proved to be safe, even in patients with cerebral hemorrhage.
Key Words: anticoagulants randomized controlled trials sinus thrombosis
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