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Evaluation of Wound Drainage After Knee or Hip Arthroplasty

NCT ID: NCT02054936

Last Updated: 2015-12-07

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

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2016-02-29

Brief Summary

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To compare side effects and complications relating to use of warfarin or rivaroxaban, tolerance and/or toxicity of these two agents such as drop in hemoglobin post operatively, extent of bruising, quantity of wound drainage, duration of drainage, wound swelling, sub and supra-therapeutic prothrombin times, need for transfusion, and patient tolerance in two randomized groups. Return visits to the operating room, length of stay, and VTE rates will also be compared.

Detailed Description

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Conditions

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Complications; Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Rivaroxaban (Xarelto)

Rivaroxaban dosing will be 10mg once daily beginning on postoperative day 1 for a duration of 30 days.

Group Type ACTIVE_COMPARATOR

Rivaroxaban (Xarelto)

Intervention Type DRUG

To date there has been little attention to evaluating differences in wound complications following TJA among patients treated with rivaroxaban compared to warfarin.

Warfarin (Coumadin)

Warfarin dosing will be titrated to achieve an INR of 2-3 and dosing will begin on postoperative day 1 for a duration of 30 days.

Group Type ACTIVE_COMPARATOR

Warfarin (Coumadin)

Intervention Type DRUG

To date there has been little attention to evaluating differences in wound complications following TJA among patients treated with rivaroxaban compared to warfarin.

Interventions

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Rivaroxaban (Xarelto)

To date there has been little attention to evaluating differences in wound complications following TJA among patients treated with rivaroxaban compared to warfarin.

Intervention Type DRUG

Warfarin (Coumadin)

To date there has been little attention to evaluating differences in wound complications following TJA among patients treated with rivaroxaban compared to warfarin.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All patients over the age of 18 undergoing primary hip or knee replacement by Dr. Urquhart or Dr. Hallstrom.

Exclusion Criteria

* Patients with a contraindication to pharmacologic VTE prophylaxis such as hemophilia, Plavix use, active bleeding or prior reaction to warfarin or rivaroxaban, nursing mothers, hepatic disease, GFR \<30, use of more than 200mg of aspirin daily, and inability to continue medication or lab monitoring after hospital discharge known preoperatively.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Andrew Urquhart

M.D. Service Chief Clinical Associate Professor, Orthopaedic Surgery Hip and Knee Replacement

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew G Urquhart, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan Health Systems

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00062541

Identifier Type: -

Identifier Source: org_study_id