The Effect of Tranexamic Acid (TXA) on Visualization During Shoulder Arthroscopy
Status unconfirmed · Phase 3
Conditions studied: Shoulder Arthroscopy, Operative Bleeding, Postoperative Pain
In brief
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.
Key facts
- Study ID
- NCT04610164
- Run by
- Rothman Institute Orthopaedics
- People needed
- 200
- Starts
- 2019-06-19
- Expected to finish
- 2020-12-31
- Last updated by the study team
- 2020-10-30
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
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.
Where it is running
- Rothman Orthopaedic Institute — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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