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

This study has been completed.

Sponsors and Collaborators: Ontario Clinical Oncology Group (OCOG)
Pfizer
Information provided by: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier: NCT00135876
  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 III

MedlinePlus related topics:   Brain Cancer    Cancer   

ChemIDplus related topics:   Heparin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   A Trial of Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients (PRODIGE)

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

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
Royal Perth Hospital    
      Perth, Western Australia, Australia, 6847
Sir Charles Gairdner Hospital    
      Nedlands, Western Australia, Australia, 6009
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
Toronto-Sunnybrook Regional Cancer Centre    
      Toronto, Ontario, Canada, M4N 3M5
Princess Margaret Hospital    
      Toronto, Ontario, Canada, M5G 2M9
The Ottawa Hospital Regional Cancer Centre    
      Ottawa, Ontario, Canada, K1H 8L6
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    
Principal Investigator:     William Geerts, MD     Toronto Sunnybrook Regional Cancer Centre    
Principal Investigator:     Jim Julian, MMath     McMaster University, Dept of Clinical Epidemiology & Biostatistics    
  More Information


Study ID Numbers:   524E-CVD-0056-013
First Received:   August 24, 2005
Last Updated:   April 25, 2007
ClinicalTrials.gov Identifier:   NCT00135876
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

Study placed in the following topic categories:
Pulmonary Embolism
Heparin, Low-Molecular-Weight
Vascular Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Venous Thromboembolism
Brain Diseases
Thrombosis
Thromboembolism
Calcium heparin
Body Weight
Brain Neoplasms
Embolism and Thrombosis
Dalteparin
Embolism
Venous Thrombosis
Glioma
Heparin
Nervous System Neoplasms

Additional relevant MeSH terms:
Fibrin Modulating Agents
Neoplasms
Anticoagulants
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents
Nervous System Diseases
Fibrinolytic Agents
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2008




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