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

May 29, 2018 updated by: Albert Einstein College of Medicine
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Drug: Normal saline
Control
Experimental: Tranexamic acid
Investigators will administer topical (1.5g) TXA during total knee arthroplasty and total hip arthroplasty
Drug: Tranexamic Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stroke
Time Frame: 1 month
1 month
Myocardial infarction
Time Frame: 1 month
1 month
Deep Vein Thrombosis
Time Frame: 1 month
1 month
Pulmonary Embolism
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albert Einstein College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2016

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

December 30, 2015

First Submitted That Met QC Criteria

December 30, 2015

First Posted (Estimate)

December 31, 2015

Study Record Updates

Last Update Posted (Actual)

May 31, 2018

Last Update Submitted That Met QC Criteria

May 29, 2018

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-5435

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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