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CompletedNCT03458468Updated Jul 30, 2019

Tranexamic Acid for the Latarjet Procedure.

An interventional study of Tranexamic Acid and Saline in Anterior Shoulder Instability, sponsored by Sports Surgery Clinic, Santry, Dublin. Completed at 1 site in Ireland. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2019-07-30.

Sponsored by Sports Surgery Clinic, Santry, Dublin · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Anterior Shoulder Instability

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Keywords

  • tranexamic acid
  • anterior shoulder instability
  • latarjet
  • hematoma
03

In context

Hematoma

109 studies on the registry are indexed under Hematoma; 19 are open to participants now.

This study's enrollment of 100 is close to the median of 107 across 83 interventional studies indexed under Hematoma.

Browse Hematoma studies →

Lead sponsor

Sports Surgery Clinic, Santry, Dublin is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Anterior shoulder instability, warranting the Latarjet procedure

Exclusion criteria

Exclusion Criteria:

  • Patients with known risk factors for hyper-coagulable state
  • Patients under 16
  • Patients unable to give consent to partake in the trial
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Group A

    Tranexamic Acid 1g IV

    Drug: Tranexamic Acid

  • Placebo comparator
    Group B

    Saline injection

    Drug: Saline

Interventions

  • DrugTranexamic Acid

    1g Tranexamic acid prior to skin incision

  • DrugSaline

    Equivalent volume of saline prior to skin incision

06

What researchers measure

Primary outcomes

  1. Hematoma Formation

    Patients hematoma formation will be evaluated using the Pauzenberger criteria (Grade 1-4)

    Time frame: Postoperative day-1

  2. Visual Analogue Scale

    Time frame: Postoperative day-1

  3. Total Drain output

    The total drain output of blood post-operatively

    Time frame: Postoperative day-1

  4. Opioid consumption

    Time frame: Postoperative day-1

Secondary outcomes

  1. Wound complications

    Time frame: Postoperative week-2

  2. Total complications

    Time frame: Postoperative month-4

  3. Haematoma Formation

    Time frame: Postoperative week-2

07

Study locations

1 site
  • Sports Surgery Clinic
    Santry, Dublin 9, Ireland
08

References and documents

Publications

  • 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. PubMed 26480877 ↗
  • 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. PubMed 28768785 ↗
  • 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. PubMed 28162887 ↗
  • 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. PubMed 28902659 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2018 to primary completion in Mar 2019, 12 months.

Of 30 non-industry interventional studies with no phase under Hematoma, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's 12 months is below that.

Counting every sponsor, half of 34 studies reached it within 15 months; a quarter within 6 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 19, 2018
First posted
Mar 8, 2018
StartActual
Mar 1, 2018
Primary completionActual
Mar 1, 2019
CompletionActual
Mar 1, 2019
Last update
Jul 30, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03458468
Lead sponsor
Sports Surgery Clinic, Santry, Dublin
Responsible party
Sponsor
First posted
Mar 8, 2018
Start date
Mar 1, 2018
Primary completion
Mar 1, 2019
Completion
Mar 1, 2019
Last update
Jul 30, 2019

Study contacts

Hannan Mullett, FRCSI
principal investigator · Sports Surgery Clinic

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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