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

The Effect of Tranexamic Acid on Visualization During Shoulder Arthroscopy

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.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain; Shoulder Arthroscopy; Operative Bleeding
• Intervention / Treatment: Drug: Tranexamic acid

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Rothman Orthopaedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group 1: TXA group; Patient will receive 1 gram intravenous TXA prior to surgery	Drug: Tranexamic acid; Prior to surgery, the patient will receive 1 gram of IV TXA
NO_INTERVENTION: Group 2: Control Group; Patient will not receive TXA prior to surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in operative factors	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.	2 hours
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

Collaborators and Investigators

• Sponsor: Rothman Institute Orthopaedics

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 19, 2019
• Primary Completion (ANTICIPATED): December 31, 2020
• Study Completion (ANTICIPATED): December 31, 2020

Study Registration Dates

• First Submitted: October 21, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (ACTUAL): October 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 30, 2020
• Last Update Submitted That Met QC Criteria: October 29, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: SNAM18d.610

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No