CClinicalTrials.gg
Sign In
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

Browse trials for

Keywords

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

Who can participate

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

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
04

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

05

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

06

Study locations

1 site
  • Sports Surgery Clinic
    Santry, Dublin 9, Ireland
07

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

08

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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hematoma→

Other studies from this sponsor

Sports Surgery Clinic, Santry, Dublin

Start the discussion