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

Venous Thromboembolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00135876
• Other study ID #: 524E-CVD-0056-013
• Status: Completed
• Phase: Phase 3
• First received: August 24, 2005
• Last updated: April 25, 2007
• Start date: October 2002
• Est. completion date: November 2006

Study information

• Verified date: April 2007
• Source: Ontario Clinical Oncology Group (OCOG)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaUnited States: Food and Drug AdministrationItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 512
• Est. completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumors
• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• dalteparin

Locations

Country	Name	City	State
Australia	The St. George Hospital	Kogarah	New South Wales
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Australia	Royal Perth Hospital	Perth	Western Australia
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Nova Scotia Cancer Centre	Halifax	Nova Scotia
Canada	The Ottawa Hospital Regional Cancer Centre	Ottawa	Ontario
Canada	Princess Margaret Hospital	Toronto	Ontario
Canada	Toronto-Sunnybrook Regional Cancer Centre	Toronto	Ontario
Canada	CancerCare Manitoba	Winnipeg	Manitoba
Italy	Ospedali Riuniti di Bergamo	Bergamo
Italy	Università di Perugia	Perugia
United States	Henry Ford Hospital	Detroit	Michigan
United States	Kellogg Cancer Center - Evanston Northwestern Healthcare	Evanston	Illinois
United States	Huntsman Cancer Institute	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Ontario Clinical Oncology Group (OCOG)	Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	objectively-proven symptomatic VTE (DVT or PE)
Secondary	bleeding (major and all bleeding)
Secondary	quality of life
Secondary	cognition assessments
Secondary	death