Clinical trial NCT03458468: Tranexamic Acid for the Latarjet Procedure.
Official title: A Randomised, Prospective Evaluation on the Effectiveness of Tranexamic Acid in Reducing Postoperative Swelling and Haematoma Formation After the Latarjet Procedure.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Shoulder Instability
Keywords: tranexamic acid
anterior shoulder instability
latarjet
hematoma
Lead sponsor: Sports Surgery Clinic, Santry, Dublin
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Hematoma Formation
timeFrame: Postoperative day-1
measure: Visual Analogue Scale
timeFrame: Postoperative day-1
measure: Total Drain output
timeFrame: Postoperative day-1
measure: Opioid consumption
timeFrame: Postoperative day-1
Secondary outcomes:
measure: Wound complications
timeFrame: Postoperative week-2
measure: Total complications
timeFrame: Postoperative month-4
measure: Haematoma Formation
timeFrame: Postoperative week-2
Other outcomes:
Locations:
city: Santry
country: Ireland
facility: Sports Surgery Clinic
state: Dublin
Study officials:
affiliation: Sports Surgery Clinic
name: Hannan Mullett, FRCSI
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.