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Clinical Trials/NCT02379663
NCT02379663CompletedPhase 4

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

Samsung Medical Center0 sites639 target enrollmentStarted: January 2012Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
639
Primary Endpoint
Major wound complication
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Oral direct Factor Xa inhibitor

Active Comparator

Rivaroxaban

Intervention: Rivaroxaban (Drug)

Low molecular weight heparin

Active Comparator

Enoxaparin

Intervention: Enoxaparin (Drug)

Normal Saline

Placebo Comparator

Normal Saline

Intervention: Normal saline (Other)

Outcomes

Primary Outcomes

Major wound complication

Time Frame: 2 weeks

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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