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

Phase 3

• Conditions: Shoulder Arthroscopy; Operative Bleeding; Postoperative Pain
• Interventions: Drug: Tranexamic acid

• Registration Number: NCT04610164
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-19
• Status Verified: 2020-10
• Study First Submitted: 2020-10-21
• Study First Submitted QC: 2020-10-29
• Last Update Submitted: 2020-10-29
• Study First Posted: 2020-10-30
• Last Update Posted: 2020-10-30
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: TXA group	Tranexamic acid	Patient will receive 1 gram intravenous TXA prior to surgery

Primary Outcome Measures

Name	Time	Method
Postoperative pain	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
Changes in operative factors	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.

Trial Locations

Locations (1)

Rothman Orthopaedic Institute; 🇺🇸 Philadelphia, Pennsylvania, United States