An interventional study of extended compression and Aspirin in Deep Vein Thrombosis, sponsored by TriHealth Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-10.
Sponsored by TriHealth Inc. · Not applicable, Interventional, and Prevention
The Cothera VPulse(tm) mechanical compression device (MCD) combines rapid intermittent sequential compression with cold therapy and is designed for single patient use in the home. Additionally, it can track patient compliance. This study will examine if there is a difference in deep vein thrombosis (DVT) occurrence over 3 weeks after tourniquet-less total knee arthroplasty (TKA) and multimodal prophylaxis with or without extended MCD use in a cooling device/MCD system.
In recent years there has been significant progress towards more effective and practical thromboprophylaxis in joint replacement surgeries. Since Aspirin 325mg twice daily has been recently included as a nationally approved venous thromboembolism (VTE) prophylaxis in the Surgical Care Improvement Project (SCIP) protocols for low risk total knee arthroplasty (TKA) patients, it is necessary to optimize multimodal prophylaxis methods. These include reduced tourniquet time, early mobilization, and mechanical compression devices (MCDs). MCDs are commonly used as part of the in-hospital VTE prophylaxis measures; however, it has not been demonstrated in clinical trials that optimal prophylaxis methods would be enhanced by prolonged use of a MCD after discharge. In order to achieve this, a potentially valuable solution has recently been made available to the outpatient population. The Cothera VPulse(tm) is a MCD that combines rapid intermittent sequential compression with cold therapy. It is designed for single patient use in the home and includes technology to track patient compliance. The purpose of this study is to examine if there is a difference in DVT occurrence over 3 weeks after tourniquet-less TKA and multimodal prophylaxis with or without extended MCD use in a cooling device/MCD system.
1,506 studies on the registry are indexed under Thrombosis; 239 are open to participants now.
This study's enrollment of 100 is close to the median of 106 across 849 interventional studies indexed under Thrombosis.
Browse Thrombosis studies →TriHealth Inc. is the lead sponsor of 99 studies on the registry; 9 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive aspirin therapy
Other: Aspirin
aspirin and extended compression therapy in combination
Device: extended compression
Home use of extended compression therapy and aspirin
standard therapy of aspirin
DVT Occurence
DVT Occurence measured by physical assessment and duplex ultrasound images for DVT detection
Time frame: 3 weeks
Patient Satisfaction
Patient satisfaction will be measured 10 days postop using the EuroQol standardized instrument
Time frame: 10 days
Mobilization
Patient activity level will be measured using the standardized UCLA Activity Score
Time frame: 10 days
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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TriHealth Inc.