Prophylaxis of Deep Vein Thrombosis Following Total Hip Arthroplasty

Samsung Medical Center

Status and phase: Completed; Phase 4

Conditions: Osteoarthritis, Hip; Femoral Neck Fractures; Femur Head Necrosis

Treatments: Other: Normal saline; Drug: Enoxaparin; Drug: Rivaroxaban

Study type: Interventional

Funder types: Other

Identifiers

NCT02379663

2011-11-012

Details and patient eligibility

About

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

Enrollment: 639 patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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639 participants in 3 patient groups, including a placebo group

Oral direct Factor Xa inhibitor

Active Comparator group

Description:

Rivaroxaban

Treatment:

Drug: Rivaroxaban

Low molecular weight heparin

Active Comparator group

Description:

Enoxaparin

Treatment:

Drug: Enoxaparin

Normal Saline

Placebo Comparator group

Description:

Normal Saline

Treatment:

Other: Normal saline