Prophylaxis of Deep Vein Thrombosis Following Total Hip Arthroplasty

Osteoarthritis, Hip Clinical Trial

Official title:

Efficacy and Safety for Prophylaxis of Deep Vein Thrombosis Following Total Hip Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02379663
• Other study ID #: 2011-11-012
• Status: Completed
• Phase: Phase 4
• First received: February 13, 2015
• Last updated: March 4, 2015
• Start date: January 2012
• Est. completion date: January 2013

Study information

• Verified date: December 2014
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This prospective study compares an oral direct factor Xa inhibitor with LMWH for thromboprophylaxis in the patients undergoing THA.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 639
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Femur Head Necrosis
• Osteoarthritis, Hip
• Venous Thrombosis

Intervention

Drug:
• Rivaroxaban
Rivaroxaban was taken orally in a dosage of 10mg once daily
• Enoxaparin
Enoxaparin was injected subcutaneously in a dosage of 40mg once daily

Other:
• Normal saline
subcutaneous injection of 1 cc of normal saline once daily

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major wound complication	hematoma : size, site woozing : frequency, amount, dressing change count infection : culture	2 weeks	No