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

NCT00135876

Last updated date
Study Location
Kellogg Cancer Center - Evanston Northwestern Healthcare
Evanston, Illinois, 60201, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Venous Thromboembolism, Brain Tumors
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Venous Thromboembolism, Brain TumorsDalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients
NCT00135876
  1. Evanston, Illinois
  2. Detroit, Michigan
  3. Salt Lake City, Utah
  4. Kogarah, New South Wales
  5. Nedlands, Western Australia
  6. Perth, Western Australia
  7. Edmonton, Alberta
  8. Winnipeg, Manitoba
  9. Halifax, Nova Scotia
  10. Ottawa, Ontario
  11. Toronto, Ontario
  12. Toronto, Ontario
  13. Bergamo,
  14. Perugia,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients
Official Title  ICMJE A Trial of Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients (PRODIGE)
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE
  • Venous Thromboembolism
  • Brain Tumors
Intervention  ICMJE Drug: dalteparin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: August 24, 2005)
512
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Italy,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00135876
Other Study ID Numbers  ICMJE 524E-CVD-0056-013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Ontario Clinical Oncology Group (OCOG)
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Chair:James Perry, MDToronto Sunnybrook Regional Cancer Centre
Principal Investigator:Mark Levine, MDOntario Clinical Oncology Group (OCOG)
Principal Investigator:William Geerts, MDToronto Sunnybrook Regional Cancer Centre
Principal Investigator:Jim Julian, MMathMcMaster University, Dept of Clinical Epidemiology & Biostatistics
PRS Account Ontario Clinical Oncology Group (OCOG)
Verification Date April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP