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

Completed · Phase 3

Conditions studied: Venous Thromboembolism, Brain Tumors

In brief

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.

Key facts

Study ID

NCT00135876

Run by

Ontario Clinical Oncology Group (OCOG)

People needed

512

Starts

2002-10-01

Expected to finish

2006-11-01

Last updated by the study team

2007-04-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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