Tranexamic Acid for the Latarjet Procedure.

NCT ID: NCT03458468

Last Updated: 2019-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Anterior Shoulder Instability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Double-blinded randomized

Study Groups

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Group A

Tranexamic Acid 1g IV

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

1g Tranexamic acid prior to skin incision

Group B

Saline injection

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Equivalent volume of saline prior to skin incision

Interventions

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Tranexamic Acid

1g Tranexamic acid prior to skin incision

Intervention Type DRUG

Saline

Equivalent volume of saline prior to skin incision

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sports Surgery Clinic, Santry, Dublin

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hannan Mullett, FRCSI

Role: PRINCIPAL_INVESTIGATOR

Sports Surgery Clinic

Locations

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Sports Surgery Clinic

Santry, Dublin, Ireland

Site Status

Countries

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Ireland

References

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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.

Reference Type BACKGROUND
PMID: 26480877 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28768785 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28162887 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28902659 (View on PubMed)

Other Identifiers

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SSC-Latarjet-001

Identifier Type: -

Identifier Source: org_study_id

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