In patients with malignant glioma, to determine the efficacy of prophylaxis with LMWH (dalteparin) compared to placebo, both commenced beyond the immediate postoperative period, for the prevention of VTE.
Patients are randomized 1:1 to receive dalteparin 5,000 anti-Xa units s.c. daily versus placebo s.c. daily. The primary outcome is VTE-free survival at 6 months. Progression free survival; overall survival, toxicity, and neurocognitive performance are secondary outcome measures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
512
Kellogg Cancer Center - Evanston Northwestern Healthcare
Evanston, Illinois, United States
Henry Ford Hospital
Detroit, Michigan, United States
Huntsman Cancer Institute
Salt Lake City, Utah, United States
objectively-proven symptomatic VTE (DVT or PE)
bleeding (major and all bleeding)
quality of life
cognition assessments
death
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The St. George Hospital
Kogarah, New South Wales, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Cross Cancer Institute
Edmonton, Alberta, Canada
CancerCare Manitoba
Winnipeg, Manitoba, Canada
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada
...and 4 more locations