Evaluation of the Therapeutic Effect of Local Application of Tranexamic Acid in Rotator Cuff Repair
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tranexamic Acid, Normal Saline.
- Who it may be relevant to
- Registry conditions: Rotator Cuff Tear Repair. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug Tranexamic Acid
Tranexamic acid (15 mg/kg) is administered through intraosseous injection into the proximal humeral cancellous bone after anesthesia induction before arthroscopic rotator cuff repair. - Drug Normal Saline
Participants receive an equivalent volume of normal saline through intraosseous injection into the proximal humeral cancellous bone after anesthesia induction before arthroscopic rotator cuff repair.
Primary outcome measures
- Arthroscopic Visual Clarity Score [Time frame: During arthroscopic rotator cuff repair surgery]
Secondary outcome measures (2)
- Irrigation Fluid Volume [Time frame: During surgery]
- Operative Time [Time frame: During surgery]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- No. 150 Ximen Road — Linhai
Publications
- Zhao J, Liang G, Huang H, Hong K, Pan J, Yang W, Liu J, Zeng L. Intravenous Tranexamic Acid Significantly Improved Visualization and Shortened the Operation Time in Arthroscopic Rotator Cuff Repair: A Systematic Review and Meta-analysis of Level I and II Studies. Arthroscopy. 2024 Feb;40(2):592-601. doi: 10.1016/j.arthro.2023.06.055. Epub 2023 Jul 7. PMID 37423470
- Xue X, Zhuang X, Zhou X, Zhu W, Lou J, Yang X, Li N. Tranexamic Acid Reduces Bleeding and Early Pain but Does Not Improve Intraoperative Visualization in Arthroscopic Rotator Cuff Repair: A Systematic Review and Meta-analysis. Arthroscopy. 2026 Mar;42(3):669-680. doi: 10.1002/arj.70089. Epub 2026 Mar 19. PMID 41856504
- Tran SQ, Itthipanichpong T, Limskul D, Thamrongskulsiri N, Tanpowpong T. Intravenous Tranexamic Acid Is Marginally Inferior to Epinephrine Irrigation for Visual Clarity During Arthroscopic Rotator Cuff Repair: A Double-Blind, Randomized Controlled Trial. Arthroscopy. 2025 Nov;41(11):4460-4468. doi: 10.1016/j.arthro.2025.05.034. Epub 2025 Jun 5. PMID 40482981
- Shin HJ, You HS, Lee K, Je LG, Kim SG, Yang KS, Jeong WK. Intravenous Tranexamic Acid Improves Visual Clarity During Synovectomy in Patients Undergoing Arthroscopic Rotator Cuff Repair: A Double-Blind, Randomized Controlled Study. Arthroscopy. 2024 May;40(5):1409-1419. doi: 10.1016/j.arthro.2023.10.019. Epub 2023 Oct 27. PMID 37890542
Identifiers
NCT: NCT07714473 · K20260564