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Completed

NCT Number: NCT03458468

Tranexamic Acid for 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.

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Key information

Conditions

Anterior Shoulder Instability Hematoma Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sports Surgery Clinic

Santry, Dublin, 9, Ireland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid

Drug

1g Tranexamic acid prior to skin incision

Saline

Drug

Equivalent volume of saline prior to skin incision

Primary outcomes

  1. Hematoma Formation

    Time frame: Postoperative day-1

    Patients hematoma formation will be evaluated using the Pauzenberger criteria (Grade 1-4)

  2. Visual Analogue Scale

    Time frame: Postoperative day-1

  3. Total Drain output

    Time frame: Postoperative day-1

    The total drain output of blood post-operatively

  4. Opioid consumption

    Time frame: Postoperative day-1

Secondary outcomes

  1. Wound complications

    Time frame: Postoperative week-2

  2. Total complications

    Time frame: Postoperative month-4

  3. Haematoma Formation

    Time frame: Postoperative week-2

Sponsors and collaborators

Lead sponsor

Sports Surgery Clinic, Santry, Dublin

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 8, 2018
Registry last updated
Jul 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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