Journal article
PRODIGE: a randomized placebo-controlled trial of dalteparin low-molecular-weight heparin thromboprophylaxis in patients with newly diagnosed malignant glioma
Journal of Thrombosis and Haemostasis, Vol.8(9), pp.1959-1965
2010
Abstract
Background and objectives: Venous thromboembolism (VTE) occurs in 20–30% of patients with malignant glioma per year of survival. We tested the efficacy of long-term dalteparin low-molecular-weight heparin (LMWH) for prevention of VTE in these patients.
Patients/methods: Adults with newly diagnosed malignant glioma were randomized to receive dalteparin 5000 anti-Xa units or placebo, both subcutaneously once daily for 6 months starting within 4 weeks of surgery. Treatment continued for up to 12 months. The primary outcome was the cumulative risk of VTE over 6 months. The target sample size was 512 patients. Events were adjudicated by a committee unaware of treatment.
Results: The trial began in 2002 and closed in May 2006 because of expiration of study medication. Ninety-nine patients were randomized to LMWH and 87 to placebo. Twenty-two patients developed VTE in the first 6 months: nine in the LMWH group and 13 in the placebo group [hazard ratio (HR) = 0.51, 95% confidence interval (CI): 0.19–1.4, P = 0.29]. At 6 months, there were three major bleeds on LMWH and none on placebo; at 12 months, 5 (5.1%) major bleeds on LMWH and 1 (1.2%) on placebo occurred (HR = 4.2, 95% CI: 0.48–36, P = 0.22). All major bleeds were intracranial and occurred while on study medication. The 12-month mortality rates were 47.8% for LMWH and 45.4% for placebo (HR = 1.2, 95% CI: 0.73–2.0, P = 0.48).
Conclusions: Trends suggesting reduced VTE and increased intracranial bleeding were seen in the LMWH thromboprophylaxis group. The role of long-term anticoagulant thromboprophylaxis in patients with brain tumors remains uncertain.
Details
- Title
- PRODIGE: a randomized placebo-controlled trial of dalteparin low-molecular-weight heparin thromboprophylaxis in patients with newly diagnosed malignant glioma
- Authors/Creators
- J.R. Perry (Author/Creator)J.A. Julian (Author/Creator)N.J. Laperriere (Author/Creator)W. Geerts (Author/Creator)G. Agnelli (Author/Creator)L.R. Rogers (Author/Creator)M.G. Malkin (Author/Creator)R. Sawaya (Author/Creator)R. Baker (Author/Creator)A. Falanga (Author/Creator)S. Parpia (Author/Creator)T. Finche (Author/Creator)M.N. Levine (Author/Creator)
- Publication Details
- Journal of Thrombosis and Haemostasis, Vol.8(9), pp.1959-1965
- Publisher
- Wiley-Blackwell
- Identifiers
- 991005540573407891
- Copyright
- © 1999 - 2017 John Wiley & Sons, Inc.
- Murdoch Affiliation
- Institute for Immunology and Infectious Diseases
- Language
- English
- Resource Type
- Journal article
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Source: InCites
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- Collaboration types
- Domestic collaboration
- International collaboration
- Citation topics
- 1 Clinical & Life Sciences
- 1.75 Blood Clotting
- 1.75.271 Venous Thromboembolism
- Web Of Science research areas
- Hematology
- Peripheral Vascular Disease
- ESI research areas
- Clinical Medicine