Overview

Prophylaxis of Deep Vein Thrombosis Following Total Hip Arthroplasty

Status:
Completed
Trial end date:
2013-01-01
Target enrollment:
0
Participant gender:
All
Summary
This prospective study compares an oral direct factor Xa inhibitor with LMWH for thromboprophylaxis in the patients undergoing THA.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Samsung Medical Center
Treatments:
Enoxaparin
Rivaroxaban
Criteria
Inclusion Criteria:

- Male or female without childbearing potential aged ≥20 years who were scheduled for
elective primary THA

Exclusion Criteria:

- recent history of active bleeding or VTE

- known genetic disorder associated with bleeding tendency or any condition related with
an increased risk of bleeding

- persistent blood pressure of ≥160mmHg systolic and/or ≥100 mmHg diastolic at baseline

- myocardial infarction or cerebrovascular accident within three months of the scheduled
surgery

- major surgery in the prior three months

- renal insufficiency with a creatinine clearance <60mL/min , hepatic failure combined
with coagulopathy, or thrombocytopenia (platelets < 100,000/mm³), or planned
indwelling epidural catheter for > 6 hours after the end of surgery