drugset / Trial / NCT07686705

Intravenous Versus Intra-articular Tranexamic Acid for Visual Clarity During Arthroscopic Rotator Cuff Repair

NCT07686705 ↗

Completed 122 enrolled Konkuk University Medical Center
RandomizedParallel-groupDouble-blindTreatment

Summary

This single-center, prospective, randomized, double-blind controlled trial evaluated whether intravenous (IV) or intra-articular (IA) administration of tranexamic acid (TXA) improves intraoperative visual clarity, compared with a no-TXA control, during arthroscopic rotator cuff repair. Patients with full-thickness rotator cuff tears were randomly allocated to one of three groups: a control group receiving no TXA; an IA group in which 500 mg of TXA was added to each 1 L of normal-saline irrigation fluid; and an IV group receiving 1000 mg of TXA intravenously 10 minutes before surgery. The operating surgeon graded visual clarity on a 0-10 numeric scale at the end of each of six predefined surgical stages. Secondary outcomes included total operative time, estimated blood loss, irrigation-fluid volume, the number of irrigation-pressure increases, postoperative shoulder swelling, and postoperative day 1 pain.

Timeline

Start
2022-05-18
Primary completion
2023-08-25
Completion
2023-08-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Tranexamic Acid Small molecule 500 mg Other
Subject Tranexamic Acid Small molecule 1000 mg Other

Indications