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Tranexamic Acid for the Latarjet Procedure.

Primary Purpose

Anterior Shoulder Instability

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Tranexamic Acid
Saline
Sponsored by
Sports Surgery Clinic, Santry, Dublin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Shoulder Instability focused on measuring tranexamic acid, anterior shoulder instability, latarjet, hematoma

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sports Surgery Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Group A

Group B

Arm Description

Tranexamic Acid 1g IV

Saline injection

Outcomes

Primary Outcome Measures

Hematoma Formation
Patients hematoma formation will be evaluated using the Pauzenberger criteria (Grade 1-4)
Visual Analogue Scale
Total Drain output
The total drain output of blood post-operatively
Opioid consumption

Secondary Outcome Measures

Wound complications
Total complications
Haematoma Formation

Full Information

First Posted
February 19, 2018
Last Updated
July 26, 2019
Sponsor
Sports Surgery Clinic, Santry, Dublin
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1. Study Identification

Unique Protocol Identification Number
NCT03458468
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
March 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sports Surgery Clinic, Santry, Dublin

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Shoulder Instability
Keywords
tranexamic acid, anterior shoulder instability, latarjet, hematoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blinded randomized
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Tranexamic Acid 1g IV
Arm Title
Group B
Arm Type
Placebo Comparator
Arm Description
Saline injection
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Intervention Description
1g Tranexamic acid prior to skin incision
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
Equivalent volume of saline prior to skin incision
Primary Outcome Measure Information:
Title
Hematoma Formation
Description
Patients hematoma formation will be evaluated using the Pauzenberger criteria (Grade 1-4)
Time Frame
Postoperative day-1
Title
Visual Analogue Scale
Time Frame
Postoperative day-1
Title
Total Drain output
Description
The total drain output of blood post-operatively
Time Frame
Postoperative day-1
Title
Opioid consumption
Time Frame
Postoperative day-1
Secondary Outcome Measure Information:
Title
Wound complications
Time Frame
Postoperative week-2
Title
Total complications
Time Frame
Postoperative month-4
Title
Haematoma Formation
Time Frame
Postoperative week-2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannan Mullett, FRCSI
Organizational Affiliation
Sports Surgery Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sports Surgery Clinic
City
Santry
State/Province
Dublin
ZIP/Postal Code
9
Country
Ireland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26480877
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.
Results Reference
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PubMed Identifier
28768785
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.
Results Reference
background
PubMed Identifier
28162887
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.
Results Reference
background
PubMed Identifier
28902659
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.
Results Reference
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Tranexamic Acid for the Latarjet Procedure.

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