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

Postoperative Pain Clinical Trial

Official title:

The Effect of Tranexamic Acid on Visualization During Shoulder Arthroscopy

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04610164
• Other study ID #: SNAM18d.610
• Status: Enrolling by invitation
• Phase: Phase 3
• Start date: June 19, 2019
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2020
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Operative Bleeding
• Pain, Postoperative
• Postoperative Pain
• Shoulder Arthroscopy

Intervention

Drug:
• Tranexamic acid
Prior to surgery, the patient will receive 1 gram of IV TXA

Locations

Country	Name	City	State
United States	Rothman Orthopaedic Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in operative factors	change in pump pressure (?P) 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 hours
Primary	Postoperative pain	Investigators will be measuring whether there is a decrease in participants pain after surgery as assessed by visual analog score 7 days after surgery	7 days