A Study of Dalteparin Prophylaxis in High-Risk Ambulatory Cancer Patients
Summary
Some cancer patients starting a new chemotherapy regimen are likely to develop blood clots, also known as venous thromboembolism (VTE). Blood clots can cause symptoms and can occasionally be life-threatening. The purpose of this study is to determine if a daily injection of a blood-thinner, dalteparin, for 12 weeks can safely and effectively reduce the frequency of blood clots. Dalteparin is currently approved for prevention of blood clots following surgery and in hospitalized patients but not specifically for cancer outpatients.
Timeline
- Start
- 2009-07
- Primary completion
- 2014-07
- Completion
- 2014-12
Outcome
Missed primary endpoint
Stopped (Enrollment): “slow enrollment and lack of continuing funds”
registry Dalteparin Injection vs No Therapy; p = 0.4795; Hazard Ratio (HR) 0.695 (95% CI 0.235 to 1.890); stratified Cox NCT00876915 ↗
registry Dalteparin Injection vs No Therapy; p = 0.0252; Hazard Ratio (HR) 7.019 (95% CI 1.236 to 131.632); stratified Cox NCT00876915 ↗
Publications
- Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12(12):CD008500. doi: 10.1002/14651858.CD008500.pub5.
- Khorana AA, Francis CW, Kuderer NM, Carrier M, Ortel TL, Wun T, Rubens D, Hobbs S, Iyer R, Peterson D, Baran A, Kaproth-Joslin K, Lyman GH. Dalteparin thromboprophylaxis in cancer patients at high risk for venous thromboembolism: A randomized trial. Thromb Res. 2017 Mar;151:89-95. doi: 10.1016/j.thromres.2017.01.009. Epub 2017 Jan 26.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dalteparin sodium | Other / unclassified | 5000 iu | Subcutaneous |