Investigation of Intravenous Tranexamic Acid With Anatomic and Reverse Total Shoulder Arthroplasty

October 4, 2021 updated by: Rush University Medical Center

Investigation of the Blood Sparing Properties of Intravenous Tranexamic Acid With Anatomic and Reverse Total Shoulder Arthroplasty

To compare intravenous Tranexamic Acid (TXA) versus normal saline placebo to determine whether or not TXA administration reduces blood loss, decrease in hemoglobin, and rate of transfusions following anatomic and reverse total shoulder arthroplasty (TSA) surgeries.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Anatomic and reverse total shoulder arthroplasty (TSA) is associated with the risk of moderate to significant blood loss that can lead to transfusions. Average estimated blood loss has been reported in the range of 354 to 361 mL intraoperatively, not accounting for additional postoperative blood loss postoperatively in surgical drains. Transfusion rates have been reported to range from 2.4% to 9.5% in recent studies, with rates over 30% for revision cases. Tranexamic acid (TXA) is a synthetic antifibrinolytic agent that is an established method of reducing blood loss and transfusion requirement for patients undergoing total hip and knee arthroplasty. TXA can be administered intravenously, topically (intraarticularly), or orally, with most available literature addressing intravenous and topical administration. Systematic reviews and meta-analyses of the total hip and knee arthroplasty literature demonstrate approximately a 30% decrease in blood loss and 50% decrease in transfusion rate with topical or intravenous administration of TXA compared to placebo. Moreover, the literature demonstrates no increased rate of thromboembolic or other complications associated with TXA administration for hip and knee arthroplasty.

Despite proven efficacy in the hip and knee arthroplasty literature, there have been no studies analyzing the ability of TXA to reduce blood loss and transfusion rate following TSA.

Purpose of the study is to compare intravenous Tranexamic Acid (TXA) versus normal saline placebo to determine whether or not TXA administration reduces blood loss, decrease in hemoglobin, and rate of transfusions following anatomic and reverse total shoulder arthroplasty (TSA) surgeries. With the hypothesis that intravenous TXA will reduce blood loss following TSA.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

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
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any patient scheduled for a primary anatomic or reverse TSA

Exclusion Criteria:

  • Allergy to TXA
  • Acquired disturbances of color vision
  • Pre-op use of anticoagulant therapy within five days before surgery
  • History of arterial or venous thromboembolic disease; such as DVT, PE, CVA, TIA
  • Pregnancy or breastfeeding
  • Recent MI (within 6 months of surgery) or any placement of stent regardless of time since placement
  • Renal impairment
  • Refusal of blood products
  • Any patient undergoing a revision TSA
  • Patients who decline to participate

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: Tranexamic Acid Group
Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.
Drug: Tranexamic Acid
Placebo Comparator: Placebo Group
Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative Blood Loss
Time Frame: Average of 3 days post-operatively
Equated based on the patient's predicted blood volume and change in hemoglobin from the pre-operative level to the lowest post-operative level.
Average of 3 days post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Units Transfused
Time Frame: Average of 3 days post-operatively
Units of pack red blood cells that the patients recieved
Average of 3 days post-operatively
Number of Patients Transfused
Time Frame: Average of 3 days post-operatively
Patients who received a post-op transfusion of pack red blood cells
Average of 3 days post-operatively
Number of Participants With Deep Vein Thrombosis
Time Frame: 30 days post-operative
Must be diagnosed via ultrasound duplex
30 days post-operative
Number of Participants With Pulmonary Embolism
Time Frame: 30 days post-operative
Must be diagnosed via CT chest or V/Q lung scan
30 days post-operative
Number of Participants With Stroke
Time Frame: 30 days post-operative
Must be diagnosed via CT scan or MRI
30 days post-operative

Collaborators and Investigators

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

Sponsor

Rush University Medical Center

Investigators

  • Principal Investigator: Gregory Cvetanovich, MD, Rush University Medical Center

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

September 1, 2015

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

October 3, 2015

First Submitted That Met QC Criteria

October 5, 2015

First Posted (Estimate)

October 7, 2015

Study Record Updates

Last Update Posted (Actual)

November 2, 2021

Last Update Submitted That Met QC Criteria

October 4, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rush TXA TSA

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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