Rotator Cuff TearNCT07442643
Epinephrine-Added Irrigation Versus Intravenous Tranexamic Acid in Arthroscopic Rotator Cuff Repair: A Prospective Randomized Controlled Trial
A study testing Epinephrine in irrigation fluid and Tranexamic acid, intravenous in people with Rotator Cuff Tear, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This single-center randomized controlled trial was designed to compare epinephrine-added irrigation fluid with an intravenous tranexamic acid (TXA) protocol during arthroscopic rotator cuff repair. The primary outcome measure was surgeon-rated surgical field visibility. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rotator Cuff Tear
- What is being tested?
- Epinephrine in irrigation fluid and Tranexamic acid, intravenous
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-70 years
- MRI-confirmed full-thickness rotator cuff tear
- Planned primary arthroscopic rotator cuff repair
- Written informed consent obtained
Who cannot join
- Age >70 years
- Advanced cardiovascular disease (advanced heart failure, uncontrolled hypertension, active ischemic heart disease)
- Significant renal impairment
- History of thromboembolic disease
- Contraindication to tranexamic acid
- Irreparable massive tear with advanced fatty degeneration or severe muscle atrophy
- Revision surgery
- Planned concomitant open surgery
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Umraniye Training and Research Hospital
Istanbul, 34766
About this study
This single-center randomized controlled trial was designed to compare epinephrine-added irrigation fluid with an intravenous tranexamic acid (TXA) protocol during arthroscopic rotator cuff repair. The primary outcome measure was surgeon-rated surgical field visibility. Secondary outcome measures included arthroscopic pump pressure, total irrigation volume, and early postoperative shoulder soft-tissue edema assessed at 24 hours.
Read the detailed description
Patients undergoing primary arthroscopic rotator cuff repair were randomized in a 1:1 ratio to receive either epinephrine-added irrigation fluid (0.33 mg/L) or an intravenous TXA regimen consisting of a 15 mg/kg bolus administered 10 minutes before surgery followed by a continuous infusion of 10 mg/kg/hour during the procedure. A pressure-controlled arthroscopic pump system was used in all cases according to a standardized protocol. Surgical field visibility was assessed using a 0-10 visual analog scale (VAS). In addition, recorded arthroscopic videos were independently evaluated by a second surgeon who was blinded to treatment allocation. Early postoperative soft-tissue edema was quantified by measuring axillary and deltoid circumferences preoperatively and at 24 hours postoperatively.
- Conditions
- Rotator Cuff Tear
- Being tested
- Epinephrine in irrigation fluid, Tranexamic acid, intravenous
- Keywords
- rotator cuff repair, shoulder arthroscopy, epinephrine, tranexamic acid
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epinephrine in irrigation fluidDrug
Description: Epinephrine added to irrigation fluid at a concentration of 0.33 mg/L during arthroscopic rotator cuff repair.
Tranexamic acid, intravenousDrug
Description:
Intravenous tranexamic acid administered as a 15 mg/kg bolus before surgery followed by continuous infusion at 10 mg/kg/hour during arthroscopic rotator cuff repair.
| Study group | Role | What they receive |
|---|---|---|
| ARM 1: Epinephrine-Added Irrigation Group | Active comparator | Participants underwent arthroscopic rotator cuff repair using irrigation fluid containing epinephrine at a concentration of 0.33 mg/L throughout the procedure. Receives: Drug: Epinephrine in irrigation fluid |
| ARM2: Intravenous Tranexamic Acid (TXA) Group | Experimental | Participants received an intravenous tranexamic acid protocol consisting of a 15 mg/kg bolus administered 10 minutes before surgery, followed by continuous infusion at 10 mg/kg/hour during arthroscopic rotator cuff repair. Receives: Drug: Tranexamic acid, intravenous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical field visibility
Surgical field visibility assessed using a 0-10 visual analog scale (VAS), calculated as the mean of scores independently assigned by two surgeons.
Measured: Intraoperative (during arthroscopic rotator cuff repair)
Secondary outcomes (6)
Mean arthroscopic pump pressure (mmHg)
Mean pressure setting of the pressure-controlled arthroscopic pump during the procedure, recorded in mmHg according to the standardized intraoperative protocol.
Measured: Intraoperative (during procedure; mean value recorded)
Total irrigation volume (liters)
Total volume of irrigation fluid used during arthroscopic rotator cuff repair, recorded in liters as the cumulative amount of irrigation bags consumed intraoperatively.
Measured: Intraoperative (total volume used during procedure)
Axillary circumference change (cm)
Change in axillary circumference on the operated side, calculated as postoperative 24-hour measurement minus the preoperative measurement (cm), obtained using a flexible tape measure with a standardized technique.
Measured: Preoperative and postoperative 24 hours
Deltoid circumference change (cm)
Change in deltoid circumference on the operated side, calculated as postoperative 24-hour measurement minus the preoperative measurement (cm), obtained using a flexible tape measure with a standardized technique.
Measured: Preoperative and postoperative 24 hours
Early postoperative complications
Incidence of early postoperative adverse events potentially related to the interventions, including cardiac arrhythmia, thromboembolic events, neurologic deficit, or allergic reactions, assessed during the immediate postoperative period.
Measured: Up to 24 hours postoperatively (or during hospitalization)
Body temperature at 24 hours (°C)
Body temperature measured at postoperative 24 hours (°C) as part of routine postoperative monitoring.
Measured: Postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start1 May 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- Model description
- Parallel assignment design in which participants were randomized to receive either epinephrine-added irrigation or an intravenous tranexamic acid protocol during arthroscopic rotator cuff repair.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ÇAĞRI ÖZCAN, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442643
- Sponsor's protocol ID
- RCR-TXA-EPINEPHRINE
- Status last verified
- Feb 2026
- First submitted
- 15 Jan 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epinephrine-Added Irrigation Versus Intravenous Tranexamic Acid in Arthroscopic Rotator Cuff Repair: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07442643
- Acronym / sponsor ID
- RCR-TXA-EPINEPHRINE
- Conditions
- Rotator Cuff Tear
- Keywords
- rotator cuff repair, shoulder arthroscopy, epinephrine, tranexamic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 2 Mar 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 single-center randomized controlled trial was designed to compare epinephrine-added irrigation fluid with an intravenous tranexamic acid (TXA) protocol during arthroscopic rotator cuff repair. The primary outcome measure was surgeon-rated surgical field visibility. Secondary outcome measures included arthroscopic pump pressure, total irrigation volume, and early postoperative shoulder soft-tissue edema assessed at 24 hours.
Detailed description
Patients undergoing primary arthroscopic rotator cuff repair were randomized in a 1:1 ratio to receive either epinephrine-added irrigation fluid (0.33 mg/L) or an intravenous TXA regimen consisting of a 15 mg/kg bolus administered 10 minutes before surgery followed by a continuous infusion of 10 mg/kg/hour during the procedure. A pressure-controlled arthroscopic pump system was used in all cases according to a standardized protocol. Surgical field visibility was assessed using a 0-10 visual analog scale (VAS). In addition, recorded arthroscopic videos were independently evaluated by a second surgeon who was blinded to treatment allocation. Early postoperative soft-tissue edema was quantified by measuring axillary and deltoid circumferences preoperatively and at 24 hours postoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel assignment design in which participants were randomized to receive either epinephrine-added irrigation or an intravenous tranexamic acid protocol during arthroscopic rotator cuff repair.
| Arm | Type | Receives |
|---|---|---|
| ARM 1: Epinephrine-Added Irrigation Group | Active comparator | Drug: Epinephrine in irrigation fluidParticipants underwent arthroscopic rotator cuff repair using irrigation fluid containing epinephrine at a concentration of 0.33 mg/L throughout the procedure. |
| ARM2: Intravenous Tranexamic Acid (TXA) Group | Experimental | Drug: Tranexamic acid, intravenousParticipants received an intravenous tranexamic acid protocol consisting of a 15 mg/kg bolus administered 10 minutes before surgery, followed by continuous infusion at 10 mg/kg/hour during arthroscopic rotator cuff repair. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-70 years
- MRI-confirmed full-thickness rotator cuff tear
- Planned primary arthroscopic rotator cuff repair
- Written informed consent obtained
Key exclusion criteria (8 listed)
- Age >70 years
- Advanced cardiovascular disease (advanced heart failure, uncontrolled hypertension, active ischemic heart disease)
- Significant renal impairment
- History of thromboembolic disease
- Contraindication to tranexamic acid
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 |
|---|---|---|
| Epinephrine in irrigation fluidDescription: Epinephrine added to irrigation fluid at a concentration of 0.33 mg/L during arthroscopic rotator cuff repair. | Drug | ARM 1: Epinephrine-Added Irrigation Group |
| Tranexamic acid, intravenousDescription: Intravenous tranexamic acid administered as a 15 mg/kg bolus before surgery followed by continuous infusion at 10 mg/kg/hour during arthroscopic rotator cuff repair. | Drug | ARM2: Intravenous Tranexamic Acid (TXA) Group |
Primary outcome
Surgical field visibility
Time frame: Intraoperative (during arthroscopic rotator cuff repair)
Surgical field visibility assessed using a 0-10 visual analog scale (VAS), calculated as the mean of scores independently assigned by two surgeons.
6 secondary outcomes
Mean arthroscopic pump pressure (mmHg)
Time frame: Intraoperative (during procedure; mean value recorded)
Total irrigation volume (liters)
Time frame: Intraoperative (total volume used during procedure)
Axillary circumference change (cm)
Time frame: Preoperative and postoperative 24 hours
Deltoid circumference change (cm)
Time frame: Preoperative and postoperative 24 hours
Early postoperative complications
Time frame: Up to 24 hours postoperatively (or during hospitalization)
Body temperature at 24 hours (°C)
Time frame: Postoperative 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epinephrine in irrigation fluid and Tranexamic acid, intravenous in people with Rotator Cuff Tear, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 8 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: finished, as of the sponsor's last update on 2 Mar 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 Turkey (Türkiye). 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical field visibility (time frame: Intraoperative (during arthroscopic rotator cuff repair)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Mar 2026.