Study Results
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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COMPLETED
NA
100 participants
INTERVENTIONAL
2018-03-01
2019-03-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group A
Tranexamic Acid 1g IV
Tranexamic Acid
1g Tranexamic acid prior to skin incision
Group B
Saline injection
Saline
Equivalent volume of saline prior to skin incision
Interventions
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Tranexamic Acid
1g Tranexamic acid prior to skin incision
Saline
Equivalent volume of saline prior to skin incision
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients under 16
* Patients unable to give consent to partake in the trial
16 Years
ALL
No
Sponsors
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Sports Surgery Clinic, Santry, Dublin
OTHER
Responsible Party
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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
Countries
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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.
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.
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.
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.
Other Identifiers
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SSC-Latarjet-001
Identifier Type: -
Identifier Source: org_study_id
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