Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Trial of Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients (PRODIGE)

Conditions
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Venous Thromboembolism, Brain Tumors

Intervention / Treatment
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* Drug: dalteparin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: dalteparin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objectively-proven symptomatic VTE (DVT or PE) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bleeding (major and all bleeding) |  |  | 
| quality of life |  |  | 
| cognition assessments |  |  | 
| death |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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deep vein thrombosis, pulmonary embolism, glioma, fragmin, anticoagulant, prophylaxis, dalteparin