NCT03027167

Outcomes Study in Patients Receiving Aspirin With Mechanical Compression Devices Versus Aspirin Alone Following Knee and Hip Arthroplasty

Outcomes Study to Determine the Incidence of Symptomatic DVT/PE in Patients Receiving Aspirin With Mechanical Compression Devices Versus Aspirin Alone Following Knee and Hip Arthroplasty

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The Purpose is to compare the safety and efficacy of the use of aspirin(ASA) with medical compression devices versus aspirin alone for venous thromboprophylaxis following knee and hip arthroplasty.

Detailed description

Venous thromboembolism (VTE), which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), is the most common complication occurring in association with knee and hip arthroplasty procedures due to an activation of the clotting cascade during bone and intramedullary canal preparation.DVT rates ranging from 4% to 15 % and PE rates ranging from 0.83% to 3% have been reported, with fatal PE rates reduced with the use of postoperative anticoagulation. The high risk of thromboembolic disease has led to recommendations that pharmacoprophylaxis be considered routinely. • The combination of short duration outpatient anticoagulation, early mobilization, and mechanical prophylaxis has recently been studied at our institution (Barnes-Jewish Hospital) and has been effective in prophylaxis against VTE. Current American College of Chest Physician (ACCP) guidelines recommend that a longer duration of outpatient anticoagulation following TKA / THA surgery may further reduce the risk of VTE. Shorter patient hospitalizations and earlier discharge require an outpatient VTE prophylaxis regimen that is simple, effective, easy to monitor, predictable, and has a high patient compliance. Currently, "routine" risk patients receive a combination of ASA 325mg BID (twice daily) for a period of 6 weeks, and portable, mobile pneumatic compression devices (MCDs) for a period of 10 days post- surgery.The study is testing to see whether the use of ASA alone can be equally effective versus the use of ASA with MCDs in "routine" risk patients following total joint arthroplasty.Patients are enrolled fpr 6 months following surgery, and data collection occurs pre-surgery, 14 days after surgery, at the 4-8 wk visit and finally, at 6 months post surgery. We are evaluating the stated outcomes over this 6 month period.

Conditions

• DVT - Deep Vein Thrombosis
• PE - Pulmonary Thromboembolism

Interventions

Type	Name	Description
DRUG	Aspirin
DEVICE	(Post- discharge) Mechanical Compression Device

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-01-01
• Completion: 2023-01-01
• First posted: 2017-01-23
• Last updated: 2017-05-12