A Randomized Controlled Trial of Enoxaparin Thromboprophylaxis in Cancer Patients With Elevated Tissue Factor Bearing Microparticles
- Because no one knows which of the study options is best, participants will be
randomized into one of the following study groups. Participants who have high levels
of TFMP in their blood will be in one of the two arms indicated.
- Arm A (High TFMP): Enoxaparin given subcutaneously (into the skin) daily for 2 months,
and lower extremity ultrasound performed at 2 months.
- Arm B (High TFMP): Observation, lower extremity ultrasound performed at 2 months.
- Arm C (Low TFMP): Observation, lower extremity ultrasound performed at 2 months.
- At 2 months, participants will have a physical examination and will be asked questions
about their general health and specific questions about any problems they might be
having. They will also have a lower extremity ultrasound and blood tests performed at
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Assess the benefit of enoxaparin in preventing venous thromboembolic events in cancer patients with high levels of circulating tissue factor bearing microparticles (TFMP).
Jeffrey Zwicker, MD
Beth Israel Deaconess Medical Center
United States: Food and Drug Administration
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|
|University of Southern California-Keck School of Medicine||Los Angeles, California 90033|
|VA Boston Healthcare System||Boston, Massachusetts 02130|
|Mass General/North Shore Cancer Center||Danvers, Massachusetts 01923|