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The Effect of Tranexamic Acid (TXA) on Visualization During Shoulder Arthroscopy

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ClinicalTrials.gov Identifier: NCT04610164
Recruitment Status : Enrolling by invitation
First Posted : October 30, 2020
Last Update Posted : October 30, 2020
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Brief Summary:
Tranexamic acid has seen an increase in use over the past decade in hip and knee arthroplasty as well as spine surgery with more recent use seen in total shoulder arthroplasty (TSA). The mechanism of action of TXA is as a lysine analogue that competitively inhibits the conversion of plasminogen to plasmin thus resulting in its antifibrinolytic activity. Investigators have showed that compared with placebo TXA had a statistically significant effect on blood and postoperative hemoglobin levels in TSA. To date there are no studies investigating the effect of TXA in arthroscopy of any kind or studies examining the ability of TXA to aid in surgeon visualization in arthroscopic procedures. The investigators of this study will use change in pump pressure as a surrogate objective measure for surgeon visualization. The hypothesis is that participants who receive TXA will have a lower change in pump pressure compared to participants who do not receive TXA.

Condition or disease Intervention/treatment Phase
Shoulder Arthroscopy Operative Bleeding Postoperative Pain Drug: Tranexamic acid Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Tranexamic Acid on Visualization During Shoulder Arthroscopy
Actual Study Start Date : June 19, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1: TXA group
Patient will receive 1 gram intravenous TXA prior to surgery
Drug: Tranexamic acid
Prior to surgery, the patient will receive 1 gram of IV TXA

No Intervention: Group 2: Control Group
Patient will not receive TXA prior to surgery



Primary Outcome Measures :
  1. Changes in operative factors [ Time Frame: 2 hours ]
    change in pump pressure (ΔP) during shoulder arthroscopy with a change in pump pressure of 15 mmHg set as the marker of surgeon visualization of the shoulder joint during surgery.

  2. Postoperative pain [ Time Frame: 7 days ]
    Investigators will be measuring whether there is a decrease in participants pain after surgery as assessed by visual analog score 7 days after surgery



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • participants aged 18-80
  • participants with an ASA (American Society of Anesthesiologists) score 1-3
  • participants with a surgical indication of full thickness small to massive rotator cuff tear.

Exclusion Criteria:

  • pregnant females,
  • participants with a known allergy to tranexamic acid,
  • participants with active thromboembolic disease,
  • participants with seizure disorder,
  • participants with prior cerebrovascular accident (CVA),
  • history of cardiac stents or past history of thromboembolic disease,
  • presence of full-thickness subscapularis tear (>50%),
  • participants with irreparable rotator cuff tears.

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): NCT04610164


Locations
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United States, Pennsylvania
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT04610164    
Other Study ID Numbers: SNAM18d.610
First Posted: October 30, 2020    Key Record Dates
Last Update Posted: October 30, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants