drugset / Trial / NCT02561923
A Study to Assess the Independent Effects of 4-Factor Prothrombin Complex Concentrate and Tranexamic Acid on Bleeding/Pharmacodynamics in Healthy Participants
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to assess the independent effects of both a 4-Factor prothrombin complex concentrate (PCC) - (Kcentra) and Tranexamic acid (TXA) on the bleeding parameters (bleeding duration and blood volume) following a punch biopsy, in addition to assessing their effects on the anticoagulant/pharmacodynamic (prothrombin time and endogenous thrombin potential) changes induced by rivaroxaban at steady state, to better understand their potential role in bleeding reversal.
Timeline
- Start
- 2015-08-27
- Primary completion
- 2016-06-17
- Completion
- 2016-06-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Prothrombin Complex Concentrate | Protein / enzyme biologic | 50 iu/kg | Intravenous |
| Subject | Rivaroxaban | Other / unclassified | 20 mg | Oral |
| Subject | Tranexamic Acid | Small molecule | 1 g | Intravenous |
Indications
No indication recorded.