Tranexamic Acid for the Latarjet Procedure.

Anterior Shoulder Instability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03458468
• Other study ID #: SSC-Latarjet-001
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: July 2019
• Source: Sports Surgery Clinic, Santry, Dublin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anterior Shoulder Instability

Intervention

Drug:
• Tranexamic Acid
1g Tranexamic acid prior to skin incision
• Saline
Equivalent volume of saline prior to skin incision

Locations

Country	Name	City	State
Ireland	Sports Surgery Clinic	Santry	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
Sports Surgery Clinic, Santry, Dublin

Country where clinical trial is conducted

Ireland, 

References & Publications (4)

Gillespie R, Shishani Y, Joseph S, Streit JJ, Gobezie R. Neer Award 2015: A randomized, prospective evaluation on the effectiveness of tranexamic acid in reducing blood loss after total shoulder arthroplasty. J Shoulder Elbow Surg. 2015 Nov;24(11):1679-84. doi: 10.1016/j.jse.2015.07.029. — View Citation

Kirsch JM, Bedi A, Horner N, Wiater JM, Pauzenberger L, Koueiter DM, Miller BS, Bhandari M, Khan M. Tranexamic Acid in Shoulder Arthroplasty: A Systematic Review and Meta-Analysis. JBJS Rev. 2017 Sep;5(9):e3. doi: 10.2106/JBJS.RVW.17.00021. Review. — View Citation

Pauzenberger L, Domej MA, Heuberer PR, Hexel M, Grieb A, Laky B, Blasl J, Anderl W. The effect of intravenous tranexamic acid on blood loss and early post-operative pain in total shoulder arthroplasty. Bone Joint J. 2017 Aug;99-B(8):1073-1079. doi: 10.1302/0301-620X.99B8.BJJ-2016-1205.R1. — View Citation

Vara AD, Koueiter DM, Pinkas DE, Gowda A, Wiater BP, Wiater JM. Intravenous tranexamic acid reduces total blood loss in reverse total shoulder arthroplasty: a prospective, double-blinded, randomized, controlled trial. J Shoulder Elbow Surg. 2017 Aug;26(8):1383-1389. doi: 10.1016/j.jse.2017.01.005. Epub 2017 Feb 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hematoma Formation	Patients hematoma formation will be evaluated using the Pauzenberger criteria (Grade 1-4)	Postoperative day-1
Primary	Visual Analogue Scale		Postoperative day-1
Primary	Total Drain output	The total drain output of blood post-operatively	Postoperative day-1
Primary	Opioid consumption		Postoperative day-1
Secondary	Wound complications		Postoperative week-2
Secondary	Total complications		Postoperative month-4
Secondary	Haematoma Formation		Postoperative week-2