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

Phase 3
18 Years
Not Enrolling
Venous Thromboembolism, Brain Tumors

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Trial Information

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

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

Inclusion Criteria:

- Both of the following criteria must be satisfied:

1. 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;

2. 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:

1. The presence of acute or chronic DVT demonstrated by duplex ultrasonography
(DUS) or venography. (Note: a screening DUS is not required for study entry);

2. Inability to commence study drug within four weeks of original surgery or

3. Serious hemorrhage requiring hospitalization, transfusion, or surgical
intervention within four weeks of potential study entry;

4. Presence of a coagulopathy (e.g. INR >1.5 or platelet count < 100x109/L);

5. 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;

6. Known acute (symptomatic or actively bleeding) gastroduodenal ulcer;

7. Familial bleeding diathesis;

8. Requiring long term anticoagulants for other reasons (e.g., mechanical heart
valves, atrial fibrillation);

9. Uncontrolled hypertension despite antihypertensive therapy;

10. Significant renal failure (dependent on dialysis or creatinine of greater than
three times upper limit of normal control);

11. Prior history of documented DVT or PE;

12. Allergy to anticoagulants (UFH, LMWH) including immune-mediated heparin-induced

13. Pregnant or of childbearing potential and not using adequate contraception;

14. Geographically inaccessible for follow-up;

15. Having an expected life span of less than 6 months;

16. Body weight < 40 kg.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Outcome Measure:

objectively-proven symptomatic VTE (DVT or PE)

Principal Investigator

James Perry, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Toronto Sunnybrook Regional Cancer Centre


Canada: Health Canada

Study ID:




Start Date:

October 2002

Completion Date:

November 2006

Related Keywords:

  • Venous Thromboembolism
  • Brain Tumors
  • deep vein thrombosis
  • pulmonary embolism
  • glioma
  • fragmin
  • anticoagulant
  • prophylaxis
  • dalteparin
  • Brain Neoplasms
  • Thromboembolism
  • Venous Thromboembolism
  • Venous Thrombosis



Henry Ford Hospital Detroit, Michigan  48202
Huntsman Cancer Institute Salt Lake City, Utah  84112
Kellogg Cancer Center - Evanston Northwestern Healthcare Evanston, Illinois  60201