ADAPTiON: Apixaban Dose Adjustment in Patient With Thrombocytopenia in ONcology
Rushad Patell
Summary
This study is being done to determine the feasibility and safety of using a novel dose adjusted apixaban for the management of participants with cancer-associated venous thromboembolism (blood clot) or and thrombocytopenia (low number of platelets in the blood). Investigators are also looking to see if participants on this treatment have fewer bleeding episodes. The name of the study drug involved in this study is: -Apixiban (a type of anticoagulant)
Description
This study is being done to determine the feasibility and safety of using a novel dose adjusted apixaban for the management of participants with cancer-associated venous thromboembolism (blood clot) or and thrombocytopenia (low number of platelets in the blood). This study is a feasibility study, which is the first-time investigators are examining this drug, Apixaban, for cancer-associate VTE or thrombocytopenia. Investigators are also looking to see if participants on this treatment have fewer bleeding episodes. The U.S. Food and Drug Administration (FDA) has approved apixaban as a treatmen…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Active malignancy defined as histologically confirmed diagnosis within last 6 months or received any cancer directed therapy within the last 6 months. * Radiologically confirmed newly diagnosed symptomatic deep vein thrombosis or pulmonary embolism within 28 days of enrollment. Includes proximal lower-limb DVT or symptomatic PE. Upper extremity or catheter-associated thrombosis will be included, as will distal lower extremity DVTs. * Platelet count \< 75,000/ml (prior to platelet transfusion) within 28 days of VTE diagnosis. * Platelet count responsive to transfusion if…
Interventions
- DrugApixaban
A factor Xa inhibitor, 2.5 and 5 mg tablets, by mouth per protocol.
Location
- Beth Israel Deaconess Medical CenterBoston, Massachusetts