Evaluation of Wound Drainage After Knee or Hip Arthroplasty

University of Michigan

Status and phase: Withdrawn; Phase 4

Conditions: Complications; Arthroplasty

Treatments: Drug: Warfarin (Coumadin); Drug: Rivaroxaban (Xarelto)

Study type: Interventional

Funder types: Other

Identifiers

NCT02054936

HUM00062541

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Rivaroxaban (Xarelto)

Active Comparator group

Description:

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

Treatment:

Drug: Rivaroxaban (Xarelto)

Warfarin (Coumadin)

Active Comparator group

Description:

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.

Treatment:

Drug: Warfarin (Coumadin)