Prophylaxis of Deep Vein Thrombosis Following Total Hip Arthroplasty

NCT02379663 | Completed Phase 4

• 1 other identifier: 2011-11-012
• Study Type: interventional
• Target: 639
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Osteoarthritis, Hip; Femur Head Necrosis; Femoral Neck Fractures

Outcome Measures

Primary Outcomes (1)

• Major wound complication

  hematoma : size, site woozing : frequency, amount, dressing change count infection : culture

  2 weeks

Study Arms (3)

Oral direct Factor Xa inhibitor

ACTIVE COMPARATOR

Rivaroxaban

Drug: Rivaroxaban

Low molecular weight heparin

ACTIVE COMPARATOR

Enoxaparin

Drug: Enoxaparin

Normal Saline

PLACEBO COMPARATOR

Normal Saline

Other: Normal saline

Interventions

Rivaroxaban DRUG

Rivaroxaban was taken orally in a dosage of 10mg once daily

Oral direct Factor Xa inhibitor

Enoxaparin DRUG

Enoxaparin was injected subcutaneously in a dosage of 40mg once daily

Low molecular weight heparin

Normal saline OTHER

subcutaneous injection of 1 cc of normal saline once daily

Normal Saline

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

MeSH Terms

Conditions

Osteoarthritis, Hip; Femur Head Necrosis; Femoral Neck Fractures

Interventions

Rivaroxaban; Enoxaparin; Saline Solution

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Osteonecrosis; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2015
• First Posted: March 5, 2015
• Study Start: January 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: March 5, 2015

Record last verified: 2014-12