Outcomes Study in Patients Receiving Aspirin With Mechanical Compression Devices Versus Aspirin Alone Following Knee and Hip Arthroplasty (PDAS)
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|ClinicalTrials.gov Identifier: NCT03027167|
Recruitment Status : Withdrawn
First Posted : January 23, 2017
Last Update Posted : May 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|DVT - Deep Vein Thrombosis PE - Pulmonary Thromboembolism||Drug: Aspirin Device: (Post- discharge) Mechanical Compression Device||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||January 2017|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2023|
Active Comparator: Aspirin and MCDs
ASA with MCDs- Patients will receive MCDs intraoperatively and during the immediate post-operative recovery period, and will receive MCDs for a period of 10 days post-surgery. ASA 325mg BID will be prescribed for a period of 6 weeks.
Device: (Post- discharge) Mechanical Compression Device
Other Name: MCD, compression pump, mobile pumps
Experimental: Aspirin only
ASA only- Patients will receive MCDs intraoperatively and during the immediate post-operative recovery period, and will NOT receive MCDs after being discharged from hospital. ASA 325mg BID will be prescribed for a period of 6 weeks.
- VTE/PE [ Time Frame: 6 months ]Using the MCS (Mobile Compression Systems) Mobile Pumps system for 10 days after surgery from hospital combined with 6 weeks of aspirin will prove superior to the use of 6 weeks of aspirin in the prophylaxis of VTE/PE in standard risk joint arthroplasty patients. Efficacy will be measured in relation to previously published clinical trials with these agents and with previous patient cohorts at our institution.
- Cessation of anticoagulation therapy for any reason [ Time Frame: 6 months ]Patient reported data will be collected to capture this information.
- Readmission to the hospital for any VTE event or surgical site complication in relation to VTE prophylaxis therapy [ Time Frame: 6 months ]Electronic Medical Records will be reviewed and patient reported data will be collected