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

NCT03027167 | Withdrawn Phase 4

• 1 other identifier: 201608075
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

DVT - Deep Vein Thrombosis; PE - Pulmonary Thromboembolism

Outcome Measures

Primary Outcomes (1)

• VTE/PE

  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.

  6 months

Secondary Outcomes (2)

• Cessation of anticoagulation therapy for any reason

  6 months

• Readmission to the hospital for any VTE event or surgical site complication in relation to VTE prophylaxis therapy

  6 months

Study Arms (2)

Aspirin and MCDs

ACTIVE COMPARATOR

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.

Drug: Aspirin; Device: (Post- discharge) Mechanical Compression Device

Aspirin only

EXPERIMENTAL

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.

Drug: Aspirin

Interventions

Aspirin DRUG

Aspirin and MCDs; Aspirin only

(Post- discharge) Mechanical Compression Device DEVICE

Also known as: MCD, compression pump, mobile pumps

Aspirin and MCDs

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All total knee arthroplasty (TKA), unicompartmental knee arthroplasty (UKA), total hip arthroplasty (THA), and surface replacement arthroplasty (SRA) patients age 18 or older and undergoing an elective primary or revision procedure will be eligible to participate in this study.

You may not qualify if:

• Patients will be excluded if they are on chronic Coumadin therapy, require prolonged immobilization (i.e. cast/knee immobilizer; inability to be full weight-bearing and out of bed on postoperative day 1), and are scheduled to have multiple surgeries in close proximity to one another. Based on our institution's risk stratification protocol, all patients deemed "high risk" and meeting one of the following criteria will also be excluded as they would receive Coumadin for VTE prophylaxis:
• Patients will be excluded if they are on chronic Coumadin therapy
• History of DVT/PE
• Active Cancer
• Hypercoaguable States (Protein C, Protein S, Factor V Leiden, etc.)
• Family history of thrombosis -note: we may remove this criteria after further discussion
• Patients requiring prolonged immobilization (i.e. cast/knee immobilizer),
• Patients having multiple surgeries in close proximity to one another.
• Patients with known allergy or hypersensitivity to Aspirin or Platelet count \< 60, 000
• Patients receiving bilateral joint replacement
• Patients who consent to the study and cancel/do not have a surgery scheduled within six months of signing the consent form will not be included. immobilization (i.e. cast/knee immobilizer; inability to be full weight-bearing and out of bed on postoperative day 1), and are scheduled to have multiple surgeries in close proximity to one another. Based on our institution's risk stratification protocol, all patients deemed "high risk" and meeting one of the following criteria will also be excluded as they would receive Coumadin for VTE prophylaxis:
• Patients will be excluded if they are on chronic Coumadin therapy
• History of DVT/PE
• Active Cancer
• Hypercoaguable States (Protein C, Protein S, Factor V Leiden, etc.)

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Medical Compression Systems: collaborator

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: January 23, 2017
• Study Start: January 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2023
• Last Updated: May 12, 2017

Record last verified: 2017-05