NCT03458468

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 8, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

July 30, 2019

Status Verified

July 1, 2019

Enrollment Period

1 year

First QC Date

February 19, 2018

Last Update Submit

July 26, 2019

Conditions

Anterior Shoulder Instability

Keywords

tranexamic acidanterior shoulder instabilitylatarjethematoma

Outcome Measures

Primary Outcomes (4)

  • Hematoma Formation

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

    Postoperative day-1

  • Visual Analogue Scale

    Postoperative day-1

  • Total Drain output

    The total drain output of blood post-operatively

    Postoperative day-1

  • Opioid consumption

    Postoperative day-1

Secondary Outcomes (3)

  • Wound complications

    Postoperative week-2

  • Total complications

    Postoperative month-4

  • Haematoma Formation

    Postoperative week-2

Study Arms (2)

Group A

EXPERIMENTAL

Tranexamic Acid 1g IV

Drug: Tranexamic Acid

Group B

PLACEBO COMPARATOR

Saline injection

Drug: Saline

Interventions

Tranexamic AcidDRUG

1g Tranexamic acid prior to skin incision

Group A
SalineDRUG

Equivalent volume of saline prior to skin incision

Group B

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Anterior shoulder instability, warranting the Latarjet procedure

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sports Surgery Clinic

Santry, Dublin, 9, Ireland

Location

Related Publications (4)

  • 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.

    PMID: 26480877BACKGROUND

  • 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.

    PMID: 28768785BACKGROUND

  • 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.

    PMID: 28162887BACKGROUND

  • 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.

    PMID: 28902659BACKGROUND

MeSH Terms

Conditions

Hematoma

Interventions

Tranexamic AcidSodium Chloride

Condition Hierarchy (Ancestors)

HemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Hannan Mullett, FRCSI

    Sports Surgery Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double-blinded randomized
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2018

First Posted

March 8, 2018

Study Start

March 1, 2018

Primary Completion

March 1, 2019

Study Completion

March 1, 2019

Last Updated

July 30, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

IE(1)