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.
Age range
18 Years – 55 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Change From Baseline in Blood Volume in Part 1
Timeframe: Day-1 (Baseline) and 4 hour (hr) postdose on Day 1
Change From Baseline in Bleeding Duration in Part 1
Timeframe: Day-1 (Baseline) and 4 hr postdose on Day 1
Mean Change in Thrombin Generation Assay (TGA) - Endogenous Thrombin Potential (ETP) Lag-time in Part 2
Timeframe: Predose (Baseline) and up to 72 hrs postdose on Day 4
Mean Change in Thrombin Generation Assay (TGA) - Endogenous Thrombin Potential (ETP) Peak in Part 2
Timeframe: Predose (Baseline) and 72 hours postdose on Day 4
Mean Change in Thrombin Generation Assay (TGA) - Endogenous Thrombin Potential (ETP) Time to Peak in Part 2
Timeframe: Predose (Baseline) and 72 hours postdose on Day 4
Mean Change in Thrombin Generation Assay (TGA) - Endogenous Thrombin Potential (ETP) Area Under Curve (AUC) in Part 2
Timeframe: Predose (Baseline) up to 72 hours on Day 4
Mean Change in Prothrombin Time (PT) in Part 2
Timeframe: Predose (Baseline) up to 72 hours on Day 4
Change From Baseline in Blood Volume in Part 2
Timeframe: Predose (Baseline) and 72 hours on Day 4
Change From Baseline in Bleeding Duration in Part 2
Timeframe: Predose (Baseline) and 72 hours on Day 4