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

NCT04610164 | Unknown Phase 3 FDA Drug

• 1 other identifier: SNAM18d.610
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Arthroscopy; Operative Bleeding; Postoperative Pain

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Group 1: TXA group

EXPERIMENTAL

Patient will receive 1 gram intravenous TXA prior to surgery

Drug: Tranexamic acid

Group 2: Control Group

NO INTERVENTION

Patient will not receive TXA prior to surgery

Interventions

Tranexamic acid DRUG

Prior to surgery, the patient will receive 1 gram of IV TXA

Group 1: TXA group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 30, 2020
• Study Start: June 19, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: October 30, 2020

Record last verified: 2020-10

Locations

US (1)