Evaluating the Use of Tranexamic Acid (TXA) in Total Joint Arthroplasty

August 31, 2021 updated by: NYU Langone Health
This research study aims to study the use of tranexamic acid (TXA) in total joint replacement (arthroplasty) of the hip (THR) and knee (TKR).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Tranexamic Acid (TXA) is given to stop or reduce heavy bleeding. It works by stopping clots from breaking down and by decreasing unwanted bleeding. It is used in many types of surgeries to help reduce surgical complications such as blood loss and blood transfusions.

In orthopaedic surgeries, such as in total hip and knee replacements, TXA has been shown to effectively reduce blood loss and transfusion requirements without an increased risk of side effects such as deep venous thrombosis (DVT) or pulmonary embolism (PE). The ability to decrease blood loss is crucial, as other studies have shown that reducing blood loss decreases morbidity and mortality in patients.

Although, many TXA dosing regimens have been studied - all of which have been useful at reducing blood loss and decreasing transfusion requirements - the best TXA dosing regimen and the most cost-effective method of TXA administration for patients have yet to be determined. Moreover, a thorough and rigorous study on the use and effects of topical and intravenous TXA and the effect of TXA on patient outcomes has yet to be conducted.

Therefore, this research study aims to address those concerns in order to understand how best to use TXA to reduce surgical complications in patients undergoing total joint replacements.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • All patients 18 years and older who are already scheduled for primary total joint arthroplasty of the hip or knee

Exclusion Criteria for IV TXA administration

  • Cardiac stent or ischemic stroke or coronary artery bypass graft (CABG)
  • If patient is on anticoagulant, patient must have documented approval from a cardiologist that patient can be removed from anticoagulant for total joint arthroplasty procedure
  • Renal impairment defined as serum Cr > 1.5 or Cr Clearance < 50 mL/min
  • Severe ischemic heart disease
  • Color blindness or problems with color vision

Criteria for Use of Topical TXA

  • Topical TXA can be used in any patient meeting one of the exclusion criteria for IV TXA administration (Section 5.3b) as there is minimal systemic absorption with topical TXA

Absolute Exclusion Criteria

  • History of deep vein thrombosis (DVT) or pulmonary embolism (PE)
  • Known congenital thrombophilia
  • History of thromboembolic or vascular disease
  • Disseminated intravascular coagulation (DIC)
  • History of seizures

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
Experimental: Intravenous Tranexamic Acid
  • 1g TXA administered intravenous piggyback at start of surgery OR
  • 1g TXA administered intravenous piggyback at start and at time of closure of surgery
Drug: Intravenous Tranexamic Acid
1g TXA IVPB (intravenous piggyback)
Other Names:
  • Tranexamic Acid
Placebo Comparator: Intravenous Placebo
- IV 0.9% sterile saline
Drug: Intravenous Placebo
IV 0.9% sterile saline
Other Names:
  • Saline
Active Comparator: Intravenous Tranexamic Acid followed by Intravenous Placebo
  • 1g TXA administered intravenous piggyback at start of surgery OR
  • 1g TXA administered intravenous piggyback at start and at time of closure of surgery
  • IV 0.9% sterile saline
Drug: Intravenous Tranexamic Acid
1g TXA IVPB (intravenous piggyback)
Other Names:
  • Tranexamic Acid
Drug: Intravenous Placebo
IV 0.9% sterile saline
Other Names:
  • Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Required a Blood Transfusion During Surgery
Time Frame: operative period (average of 1 hour)
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
operative period (average of 1 hour)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Levels of Hematocrit: Pre-operative to Post-operative
Time Frame: Day 3 or 4 post surgery
Multiple efforts were made to locate the study data, but were unsuccessful (study was terminated, data was not saved). No study data are available.
Day 3 or 4 post surgery
Length of Hospital Stay
Time Frame: At Hospital Discharge
Measured in Days
At Hospital Discharge
Estimated Blood Loss During Surgery
Time Frame: Operative period (an average of 1 hour)
Surgeon estimated blood loss
Operative period (an average of 1 hour)
Change in Hemoglobin: Pre-operative to Post-operative
Time Frame: Day 3 or 4 post surgery
Measured in grams/deciliter
Day 3 or 4 post surgery
Walking Distance Post Total Joint Arthroplasty of the Hip
Time Frame: 4 Days
Walking distance (feet) will be assessed and documented throughout the hospital stay
4 Days

Collaborators and Investigators

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

Sponsor

NYU Langone Health

Collaborators

Winthrop University Hospital

Investigators

  • Principal Investigator: Jan A Koenig, M.D., Winthrop University Hospital

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 (Actual)

April 21, 2015

Primary Completion (Actual)

July 26, 2016

Study Completion (Actual)

September 6, 2016

Study Registration Dates

First Submitted

December 23, 2015

First Submitted That Met QC Criteria

January 29, 2019

First Posted (Actual)

February 1, 2019

Study Record Updates

Last Update Posted (Actual)

September 28, 2021

Last Update Submitted That Met QC Criteria

August 31, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WUH 592498-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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