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

NCT04610164 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-10-30

No results posted yet for this study

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.

Conditions

  • Shoulder Arthroscopy
  • Operative Bleeding
  • Postoperative Pain

Interventions

DRUG

Tranexamic acid

Prior to surgery, the patient will receive 1 gram of IV TXA

Sponsors & Collaborators

  • Rothman Institute Orthopaedics

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-19
Primary Completion
2020-12-31
Completion
2020-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04610164 on ClinicalTrials.gov