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Tranexamic Acid for the Latarjet Procedure.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03458468
Recruitment Status : Completed
First Posted : March 8, 2018
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
Sports Surgery Clinic, Santry, Dublin

Study Description
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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.


Condition or disease Intervention/treatment Phase
Anterior Shoulder Instability Drug: Tranexamic Acid Drug: Saline Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blinded randomized
Primary Purpose: Treatment
Official Title: A Randomised, Prospective Evaluation on the Effectiveness of Tranexamic Acid in Reducing Postoperative Swelling and Haematoma Formation After the Latarjet Procedure.
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A
Tranexamic Acid 1g IV
 Drug: Tranexamic Acid
1g Tranexamic acid prior to skin incision
Placebo Comparator: Group B
Saline injection
 Drug: Saline
Equivalent volume of saline prior to skin incision


Outcome Measures
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Primary Outcome Measures :
  1. Hematoma Formation [ Time Frame: Postoperative day-1 ]
    Patients hematoma formation will be evaluated using the Pauzenberger criteria (Grade 1-4)

  2. Visual Analogue Scale [ Time Frame: Postoperative day-1 ]
  3. Total Drain output [ Time Frame: Postoperative day-1 ]
    The total drain output of blood post-operatively

  4. Opioid consumption [ Time Frame: Postoperative day-1 ]

Secondary Outcome Measures :
  1. Wound complications [ Time Frame: Postoperative week-2 ]
  2. Total complications [ Time Frame: Postoperative month-4 ]
  3. Haematoma Formation [ Time Frame: Postoperative week-2 ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03458468


Locations
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Ireland
Sports Surgery Clinic
Santry, Dublin, Ireland, 9
Sponsors and Collaborators
Sports Surgery Clinic, Santry, Dublin
Investigators
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Principal Investigator: Hannan Mullett, FRCSI Sports Surgery Clinic
More Information
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Publications:

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Responsible Party: Sports Surgery Clinic, Santry, Dublin
ClinicalTrials.gov Identifier: NCT03458468    
Other Study ID Numbers: SSC-Latarjet-001
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sports Surgery Clinic, Santry, Dublin:
tranexamic acid
anterior shoulder instability
latarjet
hematoma
Additional relevant MeSH terms:
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Hematoma
Hemorrhage
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
 Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants