drugset / Trial / NCT04610164

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

NCT04610164

Phase 3 Unknown 200 enrolled Rothman Institute Orthopaedics
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2019-06-19
Primary completion
2020-12-31
Completion
2020-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Tranexamic Acid Small molecule 1 g Intravenous

Indications

No indication recorded.