A Study of the Safety and Effectiveness of Apixaban in Preventing Blood Clots in Children With Leukemia Who Have a Central Venous Catheter and Are Treated With Asparaginase
NCT02369653 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 512
Last updated 2022-03-08
Summary
The purpose of this study is to compare the effect of a blood thinning drug called Apixaban versus no administration of a blood thinning drug, in preventing blood clots in children with leukemia or lymphoma. Patients must be receiving chemotherapy, including asparaginase, and have a central line (a catheter inserted for administration of medications and blood sampling)
Conditions
Interventions
- DRUG
-
Apixaban
- OTHER
-
No systemic anticoagulant prophylaxis
Sponsors & Collaborators
- collaborator INDUSTRY
- lead INDUSTRY
Principal Investigators
-
Bristol-Myers Squibb · Bristol-Myers Squibb
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 1 Year
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-10-22
- Primary Completion
- 2021-07-07
- Completion
- 2021-07-07
- FDA Drug
- Yes
Countries
- United States
- Australia
- Belgium
- Canada
- Czechia
- Hungary
- Mexico
- New Zealand
- Poland
- Puerto Rico
- Russia
- South Korea
Study Locations
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