This application to NHLBI Clinical Trial Pilot Studies describes a pilot clinical study to assess a risk-directed approach to thromboprophylaxis in hospitalized cancer patients at high risk for thrombosis. Venous thromboembolism is a leading cause of preventable in-hospital mortality and hospitalized cancer patients are at a particularly high risk for venous thromboembolic embolic events. The rate of thrombosis in cancer patients often exceeds 10% despite receiving recommended pharmacologic thromboprophylaxis. Cancer patients are also at increased risk of hemorrhage but there is a lack of data supporting the safety pharmacologic thromboprophylaxis in hospitalized cancer patients. We propose a pilot trial in hospitalized cancer patients identified as high risk for thrombosis using a cancer-adjuste prediction model. Patients will be randomized to thromboprophylaxis with standard dose enoxaparin versus intermediate-dose enoxaparin. The primary goals of this pilot trial are: a) to better define the rate of venous thromboembolic events in cancer patients at high risk for thrombosis prescribed standard low molecular weight heparin; b) to assess the rate of major hemorrhage in cancer patients receiving a modified dose of enoxaparin thromboprophylaxis; and c) refine current risk models and the evaluation novel biomarkers such as tissue factor bearing microparticles in order to improve the specificity of risk-directed thromboprophylaxis strategies. These data will enable the conduct of the first randomized phase III clinical trial designed to evaluate the efficacy and safety of thromboprophylaxis in hospitalized cancer patients.

Public Health Relevance

Venous thromboembolism is a leading cause of in-hospital mortality. Cancer patients are at a particularly high risk of suffering thromboembolic events during hospitalization. The risks and benefit of the current standard approach to thromboprophylaxis of hospitalized cancer patients is unclear. This pilot trial is designed to evaluate the risk of hemorrhage and thrombosis in high risk cancer patients receiving standard dose enoxaparin or intermediate-dose enoxaparin. These data will enable the conduct of a phase III trial to evaluate the efficacy of a targeted approach to more intense thromboprophylaxis in cancer patients at greatest risk of venous thromboembolic events.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Planning Grant (R34)
Project #
5R34HL127156-03
Application #
9417060
Study Section
Clinical Trials Review Committee (CLTR)
Program Officer
Kindzelski, Andrei L
Project Start
2016-02-10
Project End
2019-01-31
Budget Start
2018-02-01
Budget End
2019-01-31
Support Year
3
Fiscal Year
2018
Total Cost
Indirect Cost
Name
Beth Israel Deaconess Medical Center
Department
Type
DUNS #
071723621
City
Boston
State
MA
Country
United States
Zip Code
02215
Patell, Rushad; Rybicki, Lisa; McCrae, Keith R et al. (2017) Predicting risk of venous thromboembolism in hospitalized cancer patients: Utility of a risk assessment tool. Am J Hematol 92:501-507