Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients
NCT00135876
ABOUT THIS STUDY
FOR MORE INFORMATION
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1-800-718-1021
- 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
- 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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Descriptive Information | |||||||||||||
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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 |
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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 | 512 | ||||||||||||
Original Enrollment ICMJE | Same as current | ||||||||||||
Actual Study Completion Date ICMJE | November 2006 | ||||||||||||
Primary Completion Date | Not Provided | ||||||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||||||||||
Sex/Gender ICMJE |
| ||||||||||||
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 |
| ||||||||||||
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 |