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

NCT ID: NCT00135876

Last Updated: 2007-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 512 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2006-11-30

Brief Summary

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

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.

Conditions

Venous Thromboembolism; Brain Tumors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

dalteparin

Intervention Type: DRUG

Eligibility Criteria

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 biopsy;

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 thrombocytopenia;

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Ontario Clinical Oncology Group (OCOG)

OTHER

Sponsor Role: lead

Principal Investigators

James Perry, MD

Role: STUDY_CHAIR

Toronto Sunnybrook Regional Cancer Centre

Mark Levine, MD

Role: PRINCIPAL_INVESTIGATOR

Ontario Clinical Oncology Group (OCOG)

William Geerts, MD

Role: PRINCIPAL_INVESTIGATOR

Toronto Sunnybrook Regional Cancer Centre

Jim Julian, MMath

Role: PRINCIPAL_INVESTIGATOR

McMaster University, Dept of Clinical Epidemiology & Biostatistics

Locations

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

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

Toronto-Sunnybrook Regional Cancer Centre

Toronto, Ontario, Canada

Princess Margaret Hospital

Toronto, Ontario, Canada

Ospedali Riuniti di Bergamo

Bergamo, , Italy

Università di Perugia

Perugia, , Italy

Countries

United States; Australia; Canada; Italy

Other Identifiers

524E-CVD-0056-013

Identifier Type: -

Identifier Source: org_study_id