Apixaban for the Acute Treatment of Venous Thromboembolism in Children
DFCI Protocol ID:
To assess the safety and extrapolated efficacy of apixaban in pediatric subjects requiring anticoagulation for the treatment of a VTE.
Children's Hospital Boston, Dana-Farber Cancer Institute
Cameron Trenor, MD,
Children's Hospital Boston
Dana-Farber Cancer Institute:
Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, email@example.com
1. 12 to <18 years of age at the time of consent.
2. Presence of an index VTE which is confirmed by imaging.
3. Intention to manage the index VTE with anticoagulation treatment for at least 12
1. Anticoagulant treatment for the index VTE for greater than 7 days prior to
2. Thrombectomy, thrombolytic therapy, or insertion of a caval filter to treat the index
3. A mechanical heart valve.
4. Active bleeding or high risk of bleeding at the time of randomization.
5. Intracranial bleed, including intraventricular hemorrhage, within 3 months prior to
6. Abnormal baseline liver function at randomization.
7. Inadequate renal function at the time of randomization.
8. Platelet count <50Ã—109 per L at randomization.
9. Uncontrolled severe hypertension at the time of randomization.
10. Use of prohibited concomitant medication at the time of randomization.
11. Female subjects who are either pregnant or breastfeeding a child.