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

NCT ID: NCT04610164

Last Updated: 2020-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-19

Study Completion Date

2020-12-31

Brief Summary

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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

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Conditions

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Shoulder Arthroscopy Operative Bleeding Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1: TXA group

Patient will receive 1 gram intravenous TXA prior to surgery

Group Type EXPERIMENTAL

Tranexamic acid

Intervention Type DRUG

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

Group 2: Control Group

Patient will not receive TXA prior to surgery

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tranexamic acid

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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SNAM18d.610

Identifier Type: -

Identifier Source: org_study_id