Tranexamic Acid for the Latarjet Procedure.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03458468
• Date of registration: 19/02/2018
• Prospective Registration: Yes
• Primary sponsor: Sports Surgery Clinic, Santry, Dublin
• Public title: Tranexamic Acid for the Latarjet Procedure.
• Scientific title: A Randomised, Prospective Evaluation on the Effectiveness of Tranexamic Acid in Reducing Postoperative Swelling and Haematoma Formation After the Latarjet Procedure.
• Date of first enrolment: March 1, 2018
• Target sample size: 100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03458468
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Ireland

Contacts

• Name: Hannan Mullett, FRCSI
• Affiliation: Sports Surgery Clinic

Key inclusion & exclusion criteria

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



Age minimum: 16 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Anterior Shoulder Instability

Intervention(s)

Drug: Saline

Drug: Tranexamic Acid

Primary Outcome(s)

Visual Analogue Scale [Time Frame: Postoperative day-1]

Hematoma Formation [Time Frame: Postoperative day-1]

Total Drain output [Time Frame: Postoperative day-1]

Opioid consumption [Time Frame: Postoperative day-1]

Secondary Outcome(s)

Total complications [Time Frame: Postoperative month-4]

Wound complications [Time Frame: Postoperative week-2]

Haematoma Formation [Time Frame: Postoperative week-2]

Secondary ID(s)

SSC-Latarjet-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors