Safety of Topical Tranexamic Acid in Total Joint Arthroplasty in High Risk Patients

Phase 4

Withdrawn

• Conditions: Myocardial Infarction; Pulmonary Embolism; Deep Vein Thrombosis; Stroke
• Interventions: Drug: Tranexamic Acid; Drug: Normal saline

• Registration Number: NCT02644473
• Lead Sponsor: Albert Einstein College of Medicine

Brief Summary

To evaluate whether there is a difference in symptomatic thromboembolism events in the subset of patients with a history of, or risk factors for thromboembolic disease for topically applied tranexamic acid in total joint arthroplasty.

Detailed Description

Tranexamic acid (TXA) has been used successfully to stop bleeding after dental procedures, removal of tonsils, prostate surgery, heavy menstrual bleeding, and eye injuries, as well as in patients with hemophilia. Intravenous TXA has also been shown to reduce blood loss, reduce transfusion requirements, and decrease length of stay for patients undergoing total knee arthroplasty and total hip arthroplasty. These benefits occur without increasing risks of thromboembolism events such as pulmonary embolism, deep venous thrombosis, myocardial infarctions, and cerebrovascular events in patients without history of, or risk factors for thromboembolic disease. Topical TXA in TJA has also been demonstrated to show the above benefits without any increase risks, as well as systemic absorption of the medication that is below the effective therapeutic plasma concentration.

Preliminary retrospective studies has demonstrated that IV TXA to be safe and effective in patients with risk factors for thromboembolic events and patients with American Society of Anesthesiologists score III or IV.

Currently, there are no prospective studies on the use of either IV or topical TXA in these higher risk patients. The goal of this study is to evaluate whether there is a difference in symptomatic thromboembolism events in the subset of patients with a history of, or risk factors for thromboembolic disease for topically applied TXA in total joint arthroplasty (TJA).

Study Timeline

• Status Verified: 2015-12
• Study First Submitted: 2015-12-30
• Study First Submitted QC: 2015-12-30
• Study First Posted: 2015-12-31
• Study Start: 2016-02
• Last Update Submitted: 2018-05-29
• Last Update Posted: 2018-05-31
• Primary Completion: 2019-01
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Presence of one or more of seven risk factors for thromboembolic events - Prior DVT, PE, MI, CVA, coronary artery stent placement, CABG, or prothrombotic condition (Factor V Leiden deficiency, protein C deficiency, antiphospholipid syndrome, etc).

Exclusion Criteria

Simultaneous bilateral, hip resurfacing, partial knee, and revision arthroplasties

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic acid	Tranexamic Acid	Investigators will administer topical (1.5g) TXA during total knee arthroplasty and total hip arthroplasty
Control	Normal saline	-

Primary Outcome Measures

Name	Time	Method
Pulmonary Embolism	1 month
Myocardial infarction	1 month
Deep Vein Thrombosis	1 month
Stroke	1 month