Rotator Cuff Tear RepairNCT07714473
Evaluation of the Therapeutic Effect of Local Application of Tranexamic Acid in Rotator Cuff Repair
A study testing Tranexamic Acid and Normal Saline in people with Rotator Cuff Tear Repair, run by Hua Luo at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rotator Cuff Tear Repair
- What is being tested?
- Tranexamic Acid and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
No. 150 Ximen Road
Linhai, Zhejiang
Hua Luo, 0576-85190460, luohua66ry@163.com
About this study
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.
- Conditions
- Rotator Cuff Tear Repair
- Being tested
- Tranexamic Acid, Normal Saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Tranexamic acid (15 mg/kg) is administered through intraosseous injection into the proximal humeral cancellous bone after anesthesia induction before arthroscopic rotator cuff repair.
Normal SalineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Intraosseous Tranexamic Acid Group | Experimental | Participants receive intraosseous tranexamic acid administration at a dose of 15 mg/kg into the proximal humeral cancellous bone after anesthesia induction before arthroscopic rotator cuff repair. Receives: Drug: Tranexamic Acid |
| Placebo Control Group | Placebo comparator | 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. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arthroscopic Visual Clarity Score
Intraoperative arthroscopic visual clarity will be assessed during different surgical stages, including glenohumeral joint debridement, acromioplasty, and rotator cuff repair. A five-grade visual clarity scoring system will be used: Grade 1: Extremely poor visualization due to severe active bleeding. The surgical field cannot be adequately visualized and the procedure cannot proceed normally.
Grade 2: Poor visualization with substantial bleeding interference. Surgical manipulation is significantly affected and additional hemostatic procedures are required.
Grade 3: Moderate visualization. Mild to moderate bleeding is present and partially interferes with visualization, but surgery can proceed after routine management.
Grade 4: Good visualization. Only minimal bleeding points are present, with limited interference and no requirement for additional hemostatic intervention.
Grade 5: Excellent visualization. The surgical field is clear with no visible bleeding points and optimal visua
Measured: During arthroscopic rotator cuff repair surgery
Secondary outcomes (2)
Irrigation Fluid Volume
Total volume of irrigation fluid (mL) used during arthroscopic rotator cuff repair.
Measured: During surgery
Operative Time
Duration of arthroscopic rotator cuff repair procedure. (Min)
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff Tear RepairStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hua Luo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hua Luo, Taizhou Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714473
- Sponsor's protocol ID
- K20260564
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared because no public data sharing plan has been established for this study.
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.
PubMed 37423470Xue 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.
PubMed 41856504Tran 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.
PubMed 40482981Shin 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.
PubMed 37890542
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Therapeutic Effect of Local Application of Tranexamic Acid in Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT07714473
- Acronym / sponsor ID
- K20260564
- Conditions
- Rotator Cuff Tear Repair
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hua LuoUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraosseous Tranexamic Acid Group | Experimental | Drug: Tranexamic AcidParticipants receive intraosseous tranexamic acid administration at a dose of 15 mg/kg into the proximal humeral cancellous bone after anesthesia induction before arthroscopic rotator cuff repair. |
| Placebo Control Group | Placebo comparator | Drug: Normal SalineParticipants receive an equivalent volume of normal saline through intraosseous injection into the proximal humeral cancellous bone after anesthesia induction before arthroscopic rotator cuff repair. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic AcidTranexamic acid (15 mg/kg) is administered through intraosseous injection into the proximal humeral cancellous bone after anesthesia induction before arthroscopic rotator cuff repair. | Drug | Intraosseous Tranexamic Acid Group |
| Normal SalineParticipants receive an equivalent volume of normal saline through intraosseous injection into the proximal humeral cancellous bone after anesthesia induction before arthroscopic rotator cuff repair. | Drug | Placebo Control Group |
Primary outcome
Arthroscopic Visual Clarity Score
Time frame: During arthroscopic rotator cuff repair surgery
Intraoperative arthroscopic visual clarity will be assessed during different surgical stages, including glenohumeral joint debridement, acromioplasty, and rotator cuff repair. A five-grade visual clarity scoring system will be used: Grade 1: Extremely poor visualization due to severe active bleeding. The surgical field cannot be adequately visualized and the procedure cannot proceed normally. Grade 2: Poor visualization with substantial bleeding interference. Surgical manipulation is significantly affected and additional hemostatic procedures are required. Grade 3: Moderate visualization. Mild to moderate bleeding is present and partially interferes with visualization, but surgery can proceed after routine management. Grade 4: Good visualization. Only minimal bleeding points are present, with limited interference and no requirement for additional hemostatic intervention. Grade 5: Excellent visualization. The surgical field is clear with no visible bleeding points and optimal visua
2 secondary outcomes
Irrigation Fluid Volume
Time frame: During surgery
Operative Time
Time frame: During surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Results publication: PubMed 37423470Zhao 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.
- Results publication: PubMed 41856504Xue 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.
- Results publication: PubMed 40482981Tran 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.
- Results publication: PubMed 37890542Shin 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.
- Individual participant dataSharing planned: No. IPD will not be shared because no public data sharing plan has been established for this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tranexamic Acid and Normal Saline in people with Rotator Cuff Tear Repair, run by Hua Luo at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hua Luo (0576-85190460, luohua66ry@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arthroscopic Visual Clarity Score (time frame: During arthroscopic rotator cuff repair surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07714473, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.