NCT04610164

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

The Effect of Tranexamic Acid on Visualization During Shoulder Arthroscopy

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Rothman Institute Orthopaedics · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	Tranexamic acid	Prior to surgery, the patient will receive 1 gram of IV TXA

Timeline

• Start date: 2019-06-19
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2020-10-30
• Last updated: 2020-10-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study