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

April 25, 2007 updated by: Ontario Clinical Oncology Group (OCOG)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

512

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Kogarah, New South Wales, Australia, 2217
        • The St. George Hospital
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital
      • Perth, Western Australia, Australia, 6847
        • Royal Perth Hospital
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Cross Cancer Institute
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • CancerCare Manitoba
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Nova Scotia Cancer Centre
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital Regional Cancer Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
      • Toronto, Ontario, Canada, M4N 3M5
        • Toronto-Sunnybrook Regional Cancer Centre
  • Italy
      • Bergamo, Italy, 24128
        • Ospedali Riuniti di Bergamo
      • Perugia, Italy, 06123
        • Università di Perugia
  • United States
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Kellogg Cancer Center - Evanston Northwestern Healthcare
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84112-5550
        • Huntsman Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
objectively-proven symptomatic VTE (DVT or PE)

Secondary Outcome Measures

Outcome Measure
quality of life
death
bleeding (major and all bleeding)
cognition assessments

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ontario Clinical Oncology Group (OCOG)

Collaborators

Pfizer

Investigators

  • Principal Investigator: Jim Julian, MMath, McMaster University, Dept of Clinical Epidemiology & Biostatistics
  • Study Chair: James Perry, MD, Toronto Sunnybrook Regional Cancer Centre
  • Principal Investigator: William Geerts, MD, Toronto Sunnybrook Regional Cancer Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

August 24, 2005

First Submitted That Met QC Criteria

August 24, 2005

First Posted (Estimate)

August 26, 2005

Study Record Updates

Last Update Posted (Estimate)

April 27, 2007

Last Update Submitted That Met QC Criteria

April 25, 2007

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 524E-CVD-0056-013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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