Trials / Completed
CompletedNCT00135876
Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients
A Trial of Dalteparin Low Molecular Weight Heparin for Primary Prophylaxis of Venous Thromboembolism in Brain Tumour Patients (PRODIGE)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 512 (planned)
- Sponsor
- Ontario Clinical Oncology Group (OCOG) · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | dalteparin |
Timeline
- Start date
- 2002-10-01
- Completion
- 2006-11-01
- First posted
- 2005-08-26
- Last updated
- 2007-04-27
Locations
14 sites across 4 countries: United States, Australia, Canada, Italy
Source: ClinicalTrials.gov record NCT00135876. Inclusion in this directory is not an endorsement.