Prophylaxis of Deep Vein Thrombosis Following Total Hip Arthroplasty

NCT ID: NCT02379663

Last Updated: 2015-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

639 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-01-31

Brief Summary

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

Detailed Description

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Conditions

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Osteoarthritis, Hip Femur Head Necrosis Femoral Neck Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Oral direct Factor Xa inhibitor

Rivaroxaban

Group Type ACTIVE_COMPARATOR

Rivaroxaban

Intervention Type DRUG

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

Low molecular weight heparin

Enoxaparin

Group Type ACTIVE_COMPARATOR

Enoxaparin

Intervention Type DRUG

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

Normal Saline

Normal Saline

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type OTHER

subcutaneous injection of 1 cc of normal saline once daily

Interventions

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Rivaroxaban

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

Intervention Type DRUG

Enoxaparin

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

Intervention Type DRUG

Normal saline

subcutaneous injection of 1 cc of normal saline once daily

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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2011-11-012

Identifier Type: -

Identifier Source: org_study_id

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