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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier:
NCT00135876
First received: August 24, 2005
Last updated: April 25, 2007
Last verified: April 2007
  Purpose

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.


Condition Intervention Phase
Venous Thromboembolism
Brain Tumors
Drug: dalteparin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Trial of Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients (PRODIGE)

Resource links provided by NLM:


Further study details as provided by Ontario Clinical Oncology Group (OCOG):

Primary Outcome Measures:
  • objectively-proven symptomatic VTE (DVT or PE)

Secondary Outcome Measures:
  • bleeding (major and all bleeding)
  • quality of life
  • cognition assessments
  • death

Estimated Enrollment: 512
Study Start Date: October 2002
Study Completion Date: November 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135876

Locations
United States, Illinois
Kellogg Cancer Center - Evanston Northwestern Healthcare
Evanston, Illinois, United States, 60201
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112-5550
Australia, New South Wales
The St. George Hospital
Kogarah, New South Wales, Australia, 2217
Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Royal Perth Hospital
Perth, Western Australia, Australia, 6847
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, Manitoba
CancerCare Manitoba
Winnipeg, Manitoba, Canada, R3E 0V9
Canada, Nova Scotia
Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario, Canada, K1H 8L6
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Toronto-Sunnybrook Regional Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
Italy
Ospedali Riuniti di Bergamo
Bergamo, Italy, 24128
Università di Perugia
Perugia, Italy, 06123
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
Pfizer
Investigators
Study Chair: James Perry, MD Toronto Sunnybrook Regional Cancer Centre
Principal Investigator: Mark Levine, MD Ontario Clinical Oncology Group (OCOG)
Principal Investigator: William Geerts, MD Toronto Sunnybrook Regional Cancer Centre
Principal Investigator: Jim Julian, MMath McMaster University, Dept of Clinical Epidemiology & Biostatistics
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00135876     History of Changes
Other Study ID Numbers: 524E-CVD-0056-013
Study First Received: August 24, 2005
Last Updated: April 25, 2007
Health Authority: Canada: Health Canada
United States: Food and Drug Administration
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Ontario Clinical Oncology Group (OCOG):
deep vein thrombosis
pulmonary embolism
glioma
fragmin
anticoagulant
prophylaxis
dalteparin

Additional relevant MeSH terms:
Brain Neoplasms
Thromboembolism
Venous Thromboembolism
Venous Thrombosis
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Embolism and Thrombosis
Neoplasms
Neoplasms by Site
Nervous System Diseases
Nervous System Neoplasms
Thrombosis
Vascular Diseases
Dalteparin
Heparin, Low-Molecular-Weight
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014