Evaluation of the Therapeutic Effect of Local Application of Tranexamic Acid in Rotator Cuff Repair
Starting soon · Not applicable · Has a placebo group
Conditions studied: Rotator Cuff Tear Repair
In brief
This prospective randomized controlled trial aims to evaluate the efficacy and safety of intraosseous tranexamic acid administration during arthroscopic rotator cuff repair. Eligible patients undergoing arthroscopic rotator cuff repair will be randomly assigned in a 1:1 ratio to receive either intraosseous tranexamic acid or intraosseous normal saline placebo. Tranexamic acid will be administered at a dose of 15 mg/kg through intraosseous injection into the proximal humerus after anesthesia induction. The primary outcome will be intraoperative arthroscopic visual clarity assessed using a five-grade visual clarity scoring system during different surgical stages. Secondary outcomes will include irrigation fluid volume, operative time, and frequency of irrigation pressure adjustments. Safety outcomes will include perioperative complications and laboratory assessments. This study will determine whether intraosseous tranexamic acid can improve visualization of the arthroscopic surgical field and optimize surgical conditions during rotator cuff repair.
Key facts
- Study ID
- NCT07714473
- Run by
- Hua Luo
- People needed
- 60
- Starts
- 2026-08-01
- Expected to finish
- 2026-12-30
- Last updated by the study team
- 2026-07-20
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age between 18 and 80 years;
- Patients diagnosed with rotator cuff tear by shoulder MRI;
- Patients scheduled for arthroscopic rotator cuff repair;
- Ability to understand the study and provide written informed consent.
You may not qualify if…
- Severe open injury or infection around the surgical area;
- Allergy to tranexamic acid;
- Previous shoulder surgery;
- Coagulation disorders;
- Current anticoagulant therapy that cannot be discontinued;
- Pregnancy.
Where it is running
- No. 150 Ximen Road — Linhai, Zhejiang, China
Full record on ClinicalTrials.gov
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