Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients
Venous Thromboembolism, Brain Tumors
About this trial
This is an interventional prevention trial for Venous Thromboembolism focused on measuring deep vein thrombosis, pulmonary embolism, glioma, fragmin, anticoagulant, prophylaxis, dalteparin
Eligibility Criteria
Inclusion Criteria: Both of the following criteria must be satisfied: Patients with newly-diagnosed pathologically-confirmed WHO Grade 3 or Grade 4 glioma (anaplastic astrocytoma, glioblastoma multiforme, gliosarcoma, anaplastic oligodendroglioma, and anaplastic mixed glioma). Tumour histology is based on local pathology review only; Patients 18 years of age or older at time of randomization Exclusion Criteria: If one or more of the following criteria are satisfied, the patient is not eligible for the study: The presence of acute or chronic DVT demonstrated by duplex ultrasonography (DUS) or venography. (Note: a screening DUS is not required for study entry); Inability to commence study drug within four weeks of original surgery or biopsy; Serious hemorrhage requiring hospitalization, transfusion, or surgical intervention within four weeks of potential study entry; Presence of a coagulopathy (e.g. INR >1.5 or platelet count < 100x109/L); Symptomatic intracranial or intratumoural bleeding. (Note: post-operative imaging of the brain is not required for study entry. Asymptomatic "routine" post-operative blood products in a post-surgical cavity are not an exclusion; Known acute (symptomatic or actively bleeding) gastroduodenal ulcer; Familial bleeding diathesis; Requiring long term anticoagulants for other reasons (e.g., mechanical heart valves, atrial fibrillation); Uncontrolled hypertension despite antihypertensive therapy; Significant renal failure (dependent on dialysis or creatinine of greater than three times upper limit of normal control); Prior history of documented DVT or PE; Allergy to anticoagulants (UFH, LMWH) including immune-mediated heparin-induced thrombocytopenia; Pregnant or of childbearing potential and not using adequate contraception; Geographically inaccessible for follow-up; Having an expected life span of less than 6 months; Body weight < 40 kg.
Sites / Locations
- Kellogg Cancer Center - Evanston Northwestern Healthcare
- Henry Ford Hospital
- Huntsman Cancer Institute
- The St. George Hospital
- Sir Charles Gairdner Hospital
- Royal Perth Hospital
- Cross Cancer Institute
- CancerCare Manitoba
- Nova Scotia Cancer Centre
- The Ottawa Hospital Regional Cancer Centre
- Toronto-Sunnybrook Regional Cancer Centre
- Princess Margaret Hospital
- Ospedali Riuniti di Bergamo
- Università di Perugia