Tranexamic Acid for the Latarjet Procedure.

July 26, 2019 updated by: Sports Surgery Clinic, Santry, Dublin

A Randomised, Prospective Evaluation on the Effectiveness of Tranexamic Acid in Reducing Postoperative Swelling and Haematoma Formation After the Latarjet Procedure.

The investigators propose a double-blinded randomized study evaluating the effectiveness of tranexamic acid in reducing postoperative swelling and haematoma formation after the Latarjet procedure.

The purpose of this study is to assess the efficacy of tranexamic acid (TXA), given via intra-articular injection at the time of surgery in patients undergoing the Latarjet procedure for shoulder instability.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

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

  • Ireland
    • Dublin
      • Santry, Dublin, Ireland, 9
        • Sports Surgery Clinic

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

• Anterior shoulder instability, warranting the Latarjet procedure

Exclusion Criteria:

  • Patients with known risk factors for hyper-coagulable state
  • Patients under 16
  • Patients unable to give consent to partake in the trial

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: Group A
Tranexamic Acid 1g IV
Drug: Tranexamic Acid
1g Tranexamic acid prior to skin incision
Placebo Comparator: Group B
Saline injection
Drug: Saline
Equivalent volume of saline prior to skin incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hematoma Formation
Time Frame: Postoperative day-1
Patients hematoma formation will be evaluated using the Pauzenberger criteria (Grade 1-4)
Postoperative day-1
Visual Analogue Scale
Time Frame: Postoperative day-1
Postoperative day-1
Total Drain output
Time Frame: Postoperative day-1
The total drain output of blood post-operatively
Postoperative day-1
Opioid consumption
Time Frame: Postoperative day-1
Postoperative day-1

Secondary Outcome Measures

Outcome Measure
Time Frame
Wound complications
Time Frame: Postoperative week-2
Postoperative week-2
Total complications
Time Frame: Postoperative month-4
Postoperative month-4
Haematoma Formation
Time Frame: Postoperative week-2
Postoperative week-2

Collaborators and Investigators

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

Sponsor

Sports Surgery Clinic, Santry, Dublin

Investigators

  • Principal Investigator: Hannan Mullett, FRCSI, Sports Surgery Clinic

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)

March 1, 2018

Primary Completion (Actual)

March 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

February 19, 2018

First Submitted That Met QC Criteria

March 1, 2018

First Posted (Actual)

March 8, 2018

Study Record Updates

Last Update Posted (Actual)

July 30, 2019

Last Update Submitted That Met QC Criteria

July 26, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SSC-Latarjet-001

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

No

Studies a U.S. FDA-regulated device product

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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