Rotator Cuff TearsPhase 4NCT05397652
Effect of Intravenous Tranexamic Acid on Visual Clarity During Shoulder Arthroscopy in the Beach Chair Position
A Phase 4 study testing Tranexamic Acid Injectable Product in people with Rotator Cuff Tears and Hemorrhage, Surgical, run by Nikola Matejcic at 1 site in Croatia.
Trial summary
Shoulder arthroscopy offers numerous advantages and has led to a continuous increase in procedural complexity. Adequate intraoperative visual clarity is essential for successful performance of the procedure and is primarily dependent on effective hemorrhage control.The aim of this prospective, double-blind, randomized… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Rotator Cuff Tears, Hemorrhage, Surgical, Shoulder Injuries
- What is being tested?
- Tranexamic Acid Injectable Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 1 siteCroatia
- Study dates
- 24 May 2021to 21 Jul 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- rotator cuff tear
Who cannot join
- allergy to tranexamic acid, paracetamol (acetaminophen), ketoprofen, tramadol or metamizole sodium
- deep vein thrombosis
- congenital thrombophilia
- coagulopathy
- thromboembolic events within the previous 12 months
- stroke or acute coronary syndrome within the previous 3 months
Show all 11Show fewer
- renal failure
- liver cirrhosis
- glaucoma or retinal vascular disorder
- chronic treatment with anticoagulant or antiplatelet therapy
- uncontrolled hypertension (systolic blood pressure > 180 mmHg)
Trial locations and contacts
1 site in 1 country.
Croatia1 site
University orthopaedic and trauma hospital
Lovran, Primorje-Gorski Kotar County, 51415
About this study
Official title: Effect of Intravenously Administered Tranexamic Acid on Intraoperative Visual Clarity, Perioperative Blood Loss and Early Postoperative Outcomes in Shoulder Arthroscopy Performed in the Beach Chair Position: A Randomized Controlled Trial
Shoulder arthroscopy offers numerous advantages and has led to a continuous increase in procedural complexity. Adequate intraoperative visual clarity is essential for successful performance of the procedure and is primarily dependent on effective hemorrhage control.The aim of this prospective, double-blind, randomized controlled study is to evaluate the effect of intravenously administered tranexamic acid (TXA) on intraoperative visual clarity, perioperative blood loss, procedure duration, and early postoperative outcomes in patients undergoing shoulder arthroscopy in the beach chair position, an area for which limited data are currently available in the literature. In both the experimental and control groups, hemoglobin levels are measured in the irrigation fluid and in patients' blood samples obtained before and after surgery. Additional outcomes include intraoperative visual clarity, duration of the procedure, postoperative shoulder swelling, postoperative pain intensity, and analgesic consumption.This study applies established scientific methods to determine whether there is a justified basis for the introduction of TXA into routine clinical practice for shoulder arthroscopy.
Read the detailed description
All surgical procedures will be performed at the University orthopaedic and trauma hospital Lovran, Croatia. Upon arrival at the hospital, the patient's body weight and height will be recorded. One day before the procedure, the patient will have blood taken from a vein and a complete blood count will be analyzed. Body weight and height were also recorded, and body mass index was calculated. Before the procedure, a physiotherapist measured the initial shoulder circumference in centimeters at three standardized measurement points: axilla-acromion (point A), axilla-deltoid (point B), and 10 cm above the olecranon (point C). The circumferences were documented on a standardized data collection form. Immediately before the procedure, patients will receive regional infiltrative (interscalene block) and general anesthesia with airway protection by endotracheal tube or laryngeal mask. Patients in the experimental group will receive 1 g of TXA in 100 ml of sterile saline IV 10 min before the start of the procedure, while patients in the control group will receive only sterile saline. The position of the patients will be beach chair with the head in the protective helmet and the arm in the front traction of 2,5 kg. All patients will be operated on by the same surgeon (NM) with the usual equipment: 4 mm 30° arthroscopic lens, arthroscopic pump basically set to 50 mmHg with the possibility of pulse increase of pressure by 20 mmHg for 2 min as needed, radiofrequency ablator and arthroscopic shaver system. Rotator cuff tendon repair will be performed using suture anchors as the primary procedure in all patients. If needed, additional procedures will be carried out, including glenohumeral (GH) stabilization by capsulolabral plication, labral repair, and long head of the biceps brachii (LHBB) tenodesis using the same implants. In cases of more severe damage or inflammation, LHBB tenotomy will be performed instead. Acromioclavicular (AC) joint repositioning and vertical stabilization will be performed using a suspensory fixation system with titanium buttons and synthetic tapes.
Other possible procedures include subacromial and subcoracoid bursectomy with soft tissue release, acromioplasty, tuberoplasty, AC joint resection, capsulotomy, synovectomy, microfracture (MFX), paralabral cyst evacuation, tendon drilling, removal of calcifications or implants, and tissue or implant sampling for histological and microbiological analysis. At the beginning of surgery and every 15 minutes thereafter, the surgeon will assess arthroscopic visibility using a Visual Analogue Scale (VAS-V) ranging from 0 (worst) to 10 (best), while being blinded to TXA allocation. Simultaneously, the endoscopic screen will be photographed with a 40 MP camera. Scores will be recorded, and images stored. Screen photos will be presented after surgery to three independent surgeons with experience in arthroscopy on visual clarity estimation (VAS range 0-10). Intraoperative data will include the number and extent of tendon lesions, presence of synovitis, operative time, mean arterial pressure (MAP), number of irrigation pressure boosts, and fluid inflow/outflow volumes. All procedures and implants will be documented. Any intraoperative complications (e.g., camera fogging, implant/instrument failure) will be noted. All administered crystalloids/colloids will be listed. Irrigation waste fluid will be collected and homogenized, and a 20 mL sample will be taken for analysis. Hemoglobin concentration will then be determined in the homogenized sample using spectrophotometry (Cripps method; University of Rijeka, Medical Faculty; Varian Cary 100 Bio, 190-900 nm, resolution ≤ 0.189 nm, wavelength accuracy ± 0.02-0.04 nm). On the first day after the surgery, the shoulder circumference will be measured at 3 typical sites and the level of pain will be noted (VAS range 0 no pain -10 the strongest pain). On the second day, the shoulder circumference measurement and estimation of the level of pain will be repeated. Also blood will be taken from a vein and complete blood count will be repeated. During the postoperative period, the amount and type of analgesic drugs administered and the length of hospitalization will be monitored.
- Conditions
- Rotator Cuff Tears, Hemorrhage, Surgical, Shoulder Injuries
- Being tested
- Tranexamic Acid Injectable Product, Placebo
- Keywords
- Arthroscopy, Hemorrhage, Shoulder, Tranexamic acid
- Medical subject headings
- Rotator Cuff Injuries, Blood Loss, Surgical, Shoulder Injuries, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid Injectable ProductDrug
Patients from the experimental group will receive 10 minutes before the procedure 1 g of tranexamic acid in 100 ml of saline intravenously unlike the patients in the control group who will receive just sterile saline.
PlaceboDrug
Patients from experimental group will receive 10 minutes before the procedure 1 g of tranexamic acid in 100 ml of saline intravenously unlike the patients in the control group who will receive just sterile saline.
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid injectable product | Experimental | Patients from the experimental group will receive 10 minutes before the procedure 1 g of tranexamic acid in 100 ml of saline intravenously Receives: Drug: Tranexamic Acid Injectable Product |
| Placebo | Placebo comparator | Patients from the control group will receive 10 minutes before the procedure 100 ml sterile saline intravenously Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Clarity on Endoscope Screen During Shoulder Arthroscopy (Intraoperative)
The operating surgeon evaluated intraoperative visual clarity using the Visual Analog Scale for visibility (VAS-V), ranging from 0 (worst visual clarity) to 10 (best visual clarity), at 15-minute intervals during shoulder arthroscopy. At each assessment time point, the endoscope screen was simultaneously photographed. The surgeon was blinded to group allocation. Visual clarity assessments performed from skin incision up to 135 minutes of surgery were included in the analysis. For each participant, all intraoperative VAS-V measurements within this period were averaged to obtain a single mean intraoperative visibility score. Higher scores indicate better visual clarity.
Measured: From skin incision to final suture (intraoperative period), assessed every 15 minutes, up to 135 minutes
Secondary outcomes (16)
Independent Assessor Visibility Rating (VAS)
Three blinded independent assessors evaluated standardized arthroscopic images projected on a screen using the Visual Analog Scale (VAS), ranging from 0 (no visibility) to 10 (optimal visibility). Images were obtained intraoperatively at predefined 15-minute time points during shoulder arthroscopy. Only images obtained from skin incision up to 135 minutes of surgery were included in the analysis. For each participant, visibility ratings from all assessors and time points within this period were averaged to obtain a single mean visibility score. Higher scores indicate better visibility.
Measured: From skin incision to final suture (intraoperative period), up to 135 minutes; image assessments performed after completion of surgery
Interobserver Agreement of Independent Assessors for Arthroscopic Visibility Ratings (VAS)
Agreement among three blinded independent assessors evaluating standardized intraoperative arthroscopic images using the Visual Analog Scale (VAS), ranging from 0 (worst visual clarity) to 10 (best visual clarity), was assessed using Cronbach's alpha. Images obtained from skin incision up to 135 minutes of surgery were included in the analysis.
Measured: After completion of surgery, following blinded assessment of standardized intraoperative arthroscopic images obtained from skin incision to final suture.
Comparison of Arthroscopic Visibility Ratings Between the Operating Surgeon and Independent Assessors (VAS)
Mean arthroscopic visibility ratings assessed using the Visual Analog Scale (VAS), ranging from 0 (no visibility) to 10 (optimal visibility), were evaluated intraoperatively by the operating surgeon at 15-minute intervals during shoulder arthroscopy and by three blinded independent assessors using standardized intraoperative arthroscopic images. Only assessments obtained from skin incision up to 135 minutes of surgery were included in the analysis. For each participant, visibility ratings within this period were averaged to obtain a single mean visibility score, and mean visibility ratings were compared between the experimental and control groups.
Measured: From skin incision to final suture (intraoperative period), assessed every 15 minutes, up to 135 minutes; independent image evaluations performed after completion of surgery
Concentration of Hemoglobin in Waste Irrigation Fluid (mg/100 mL)
Hemoglobin concentration was determined spectrophotometrically from homogenized waste irrigation fluid samples collected throughout shoulder arthroscopy. For each participant, a single hemoglobin concentration value was obtained from the total collected irrigation fluid during the intraoperative period.
Measured: From skin incision to final suture (intraoperative period)
Number of Irrigation Pump Pressure-boost Events
The number of arthroscopic pump pressure-boost events, defined as transient increases in irrigation pressure of 20 mmHg sustained for a 2-minute period, was recorded throughout shoulder arthroscopy. For each participant, the total number of pressure-boost events occurring during the intraoperative period was recorded.
Measured: From skin incision to final suture (intraoperative period)
Total Irrigation Fluid Volume Used (L)
The total volume of irrigation fluid used during shoulder arthroscopy was recorded throughout the surgical procedure. For each participant, the cumulative irrigation fluid volume used during the intraoperative period was calculated and expressed in liters.
Measured: From skin incision to final suture (intraoperative period)
Intraoperative Mean Arterial Pressure (MAP), mmHg
Mean arterial pressure (MAP) values were continuously recorded from the anesthesia machine throughout shoulder arthroscopy. For each participant, all intraoperative MAP measurements were averaged to obtain a single mean intraoperative MAP value, expressed in mmHg.
Measured: From skin incision to final suture (intraoperative period)
Duration of Surgery (Minutes)
The duration of surgery was recorded for each participant as the time from skin incision to final suture and expressed in minutes.
Measured: From skin incision to final suture (intraoperative period)
Intraoperative Blood Loss (mL)
Intraoperative blood loss was calculated for each participant based on hemoglobin concentration measured spectrophotometrically in homogenized waste irrigation fluid collected throughout shoulder arthroscopy, in combination with the total volume of irrigation fluid used during the intraoperative period. The result was expressed as total intraoperative blood loss in milliliters (mL).
Measured: From skin incision to final suture (intraoperative period)
Total Perioperative Blood Loss (mL)
Total perioperative blood loss was calculated using the Gross formula based on changes in hematocrit values from the preoperative baseline to postoperative day 2.
Measured: From preoperative baseline (measured 1 day before surgery) to postoperative day 2
Postoperative (Hidden) Blood Loss (mL)
Postoperative (hidden) blood loss was calculated by subtracting the intraoperative blood loss from the total perioperative blood loss.
Measured: From completion of surgery (final suture) to postoperative day 2
Perioperative Drop in Hemoglobin (g/dL)
The perioperative decrease in hemoglobin concentration was calculated as the difference between the preoperative baseline value and the value measured on postoperative day 2.
Measured: From preoperative baseline (measured 1 day before surgery) to postoperative day 2
Change in Upper-arm Circumference (cm) as Marker of Swelling
Upper-arm circumference was measured using a measuring tape at three predefined anatomical points (A, B, and C) on the operated upper arm. Measurements were obtained preoperatively and on postoperative days 1 and 2. For each participant, measurements at points A, B, and C were averaged to obtain a single mean circumference value at each time point. Postoperative swelling was expressed as the change in mean upper-arm circumference from baseline to postoperative day 2.
Measured: From preoperative baseline (measured 1 day before surgery) to postoperative day 2
Postoperative Pain (VAS, 0-10)
Postoperative pain was assessed by the patient using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst pain). Pain intensity was recorded on postoperative day 1 and postoperative day 2. For each participant, pain scores from postoperative days 1 and 2 were averaged to obtain a single mean postoperative pain score. Higher scores indicate greater pain intensity.
Measured: From postoperative day 1 to postoperative day 2
Total Postoperative Analgesic Consumption (mg)
Total postoperative analgesic consumption was calculated as the cumulative dose of all orally and intravenously administered analgesics, including paracetamol (acetaminophen), ketoprofen, tramadol, and metamizole, from the end of surgery until hospital discharge.
Measured: From completion of surgery (final suture) until hospital discharge (postoperative inpatient period), up to 7 days
Length of Hospital Stay (Days)
The length of hospital stay was recorded as the number of days each patient spent in the hospital following surgery until discharge.
Measured: From surgery until hospital discharge (postoperative inpatient period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start24 May 2021
- Primary completion21 Jul 2023
- Study completion21 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff TearsStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nikola Matejcic
- Sponsor type
- University, hospital or other
- Collaborators
- University orthopaedic and trauma hospital Lovran, University of Rijeka, University of Zagreb, The Faculty of Kinesiology
- Responsible party
- Sponsor-investigator, Nikola Matejcic, Clinic for Orthopedics Lovran
- Investigators
- Nikola Matejcic, MD, Principal investigator, University orthopaedic and trauma hospital Lovran, Croatia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397652
- Sponsor's protocol ID
- MATTXA2022
- Status last verified
- Jan 2026
- First submitted
- 18 May 2022
- Last updated
- 24 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There will be a limit of access only to patients names
Publications
Liu YF, Hong CK, Hsu KL, Kuan FC, Chen Y, Yeh ML, Su WR. Intravenous Administration of Tranexamic Acid Significantly Improved Clarity of the Visual Field in Arthroscopic Shoulder Surgery. A Prospective, Double-Blind, and Randomized Controlled Trial. Arthroscopy. 2020 Mar;36(3):640-647. doi: 10.1016/j.arthro.2019.10.020. Epub 2019 Dec 20.
PubMed 31870749Ersin M, Demirel M, Buget MI, Edipoglu IS, Atalar AC, Ersen A. The effect of intravenous tranexamic acid on visual clarity during arthroscopic rotator cuff repair: A randomized, double-blinded, placebo-controlled pilot study. Acta Orthop Traumatol Turc. 2020 Nov;54(6):572-576. doi: 10.5152/j.aott.2020.19164.
PubMed 33423986Cripps CM. Rapid method for the estimation of plasma haemoglobin levels. J Clin Pathol. 1968 Jan;21(1):110-2. doi: 10.1136/jcp.21.1.110. No abstract available.
PubMed 5697326Parker JD, Lim KS, Kieser DC, Woodfield TBF, Hooper GJ. Is tranexamic acid toxic to articular cartilage when administered topically? What is the safe dose? Bone Joint J. 2018 Mar 1;100-B(3):404-412. doi: 10.1302/0301-620X.100B3.BJJ-2017-1135.R1.
PubMed 29589496Gao HL, Zhang JC, He Y, Zhai WT, Xiao LB, Shi Q. [Clinical study on the control of intra-articular hemorrhage by tranexamic acid after shoulder arthroscopy]. Zhongguo Gu Shang. 2020 Mar 25;33(3):238-41. doi: 10.12200/j.issn.1003-0034.2020.03.010. Chinese.
PubMed 32233251Bayram E, Yildirim C, Erturk AK, Yilmaz M, Atlihan D. Comparison of the efficacy of irrigation with epinephrine or tranexamic acid on visual clarity during arthroscopic rotator cuff repair: A double-blind, randomized-controlled study. Jt Dis Relat Surg. 2021;32(1):115-121. doi: 10.5606/ehc.2021.78393. Epub 2021 Jan 6.
PubMed 33463426Hartland AW, Teoh KH, Rashid MS. Clinical Effectiveness of Intraoperative Tranexamic Acid Use in Shoulder Surgery: A Systematic Review and Meta-analysis. Am J Sports Med. 2021 Sep;49(11):3145-3154. doi: 10.1177/0363546520981679. Epub 2021 Jan 21.
PubMed 33475421Belk JW, McCarty EC, Houck DA, Dragoo JL, Savoie FH, Thon SG. Tranexamic Acid Use in Knee and Shoulder Arthroscopy Leads to Improved Outcomes and Fewer Hemarthrosis-Related Complications: A Systematic Review of Level I and II Studies. Arthroscopy. 2021 Apr;37(4):1323-1333. doi: 10.1016/j.arthro.2020.11.051. Epub 2020 Dec 2.
PubMed 33278534Rodriguez-Merchan EC. Tranexamic acid is effective in decreasing postoperative intraarticular bleeding in arthroscopic knee surgery. Blood Coagul Fibrinolysis. 2020 Apr;31(3):175-178. doi: 10.1097/MBC.0000000000000895.
PubMed 31990755Kirsch JM, Bedi A, Horner N, Wiater JM, Pauzenberger L, Koueiter DM, Miller BS, Bhandari M, Khan M. Tranexamic Acid in Shoulder Arthroplasty: A Systematic Review and Meta-Analysis. JBJS Rev. 2017 Sep;5(9):e3. doi: 10.2106/JBJS.RVW.17.00021.
PubMed 28902659Goldstein M, Feldmann C, Wulf H, Wiesmann T. Tranexamic Acid Prophylaxis in Hip and Knee Joint Replacement. Dtsch Arztebl Int. 2017 Dec 1;114(48):824-830. doi: 10.3238/arztebl.2017.0824.
PubMed 29249226Ng W, Jerath A, Wasowicz M. Tranexamic acid: a clinical review. Anaesthesiol Intensive Ther. 2015;47(4):339-50. doi: 10.5603/AIT.a2015.0011. Epub 2015 Mar 23.
PubMed 25797505van Montfoort DO, van Kampen PM, Huijsmans PE. Epinephrine Diluted Saline-Irrigation Fluid in Arthroscopic Shoulder Surgery: A Significant Improvement of Clarity of Visual Field and Shortening of Total Operation Time. A Randomized Controlled Trial. Arthroscopy. 2016 Mar;32(3):436-44. doi: 10.1016/j.arthro.2015.08.027.
PubMed 26524933Weber SC, Abrams JS, Nottage WM. Complications associated with arthroscopic shoulder surgery. Arthroscopy. 2002 Feb;18(2 Suppl 1):88-95. doi: 10.1053/jars.2002.31801.
PubMed 11828349Memon M, Kay J, Gholami A, Simunovic N, Ayeni OR. Fluid Extravasation in Shoulder Arthroscopic Surgery: A Systematic Review. Orthop J Sports Med. 2018 May 14;6(5):2325967118771616. doi: 10.1177/2325967118771616. eCollection 2018 May.
PubMed 29785406
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenously Administered Tranexamic Acid on Intraoperative Visual Clarity, Perioperative Blood Loss and Early Postoperative Outcomes in Shoulder Arthroscopy Performed in the Beach Chair Position: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05397652
- Acronym / sponsor ID
- MATTXA2022
- Conditions
- Rotator Cuff Tears, Hemorrhage, Surgical, Shoulder Injuries
- Keywords
- Arthroscopy, Hemorrhage, Shoulder, Tranexamic acid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Nikola MatejcicUniversity, hospital or other
- Collaborators
- University orthopaedic and trauma hospital Lovran, University of Rijeka, University of Zagreb, The Faculty of Kinesiology
- Study start
- 24 May 2021 (actual)
- Primary completion
- 21 Jul 2023 (actual)
- Study completion
- 21 Jul 2023 (actual)
- First posted
- 31 May 2022 (actual)
- Results
- Posted 24 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Shoulder arthroscopy offers numerous advantages and has led to a continuous increase in procedural complexity. Adequate intraoperative visual clarity is essential for successful performance of the procedure and is primarily dependent on effective hemorrhage control.The aim of this prospective, double-blind, randomized controlled study is to evaluate the effect of intravenously administered tranexamic acid (TXA) on intraoperative visual clarity, perioperative blood loss, procedure duration, and early postoperative outcomes in patients undergoing shoulder arthroscopy in the beach chair position, an area for which limited data are currently available in the literature. In both the experimental and control groups, hemoglobin levels are measured in the irrigation fluid and in patients' blood samples obtained before and after surgery. Additional outcomes include intraoperative visual clarity, duration of the procedure, postoperative shoulder swelling, postoperative pain intensity, and analgesic consumption.This study applies established scientific methods to determine whether there is a justified basis for the introduction of TXA into routine clinical practice for shoulder arthroscopy.
Detailed description
All surgical procedures will be performed at the University orthopaedic and trauma hospital Lovran, Croatia. Upon arrival at the hospital, the patient's body weight and height will be recorded. One day before the procedure, the patient will have blood taken from a vein and a complete blood count will be analyzed. Body weight and height were also recorded, and body mass index was calculated. Before the procedure, a physiotherapist measured the initial shoulder circumference in centimeters at three standardized measurement points: axilla-acromion (point A), axilla-deltoid (point B), and 10 cm above the olecranon (point C). The circumferences were documented on a standardized data collection form. Immediately before the procedure, patients will receive regional infiltrative (interscalene block) and general anesthesia with airway protection by endotracheal tube or laryngeal mask. Patients in the experimental group will receive 1 g of TXA in 100 ml of sterile saline IV 10 min before the start of the procedure, while patients in the control group will receive only sterile saline. The position of the patients will be beach chair with the head in the protective helmet and the arm in the front traction of 2,5 kg. All patients will be operated on by the same surgeon (NM) with the usual equipment: 4 mm 30° arthroscopic lens, arthroscopic pump basically set to 50 mmHg with the possibility of pulse increase of pressure by 20 mmHg for 2 min as needed, radiofrequency ablator and arthroscopic shaver system. Rotator cuff tendon repair will be performed using suture anchors as the primary procedure in all patients. If needed, additional procedures will be carried out, including glenohumeral (GH) stabilization by capsulolabral plication, labral repair, and long head of the biceps brachii (LHBB) tenodesis using the same implants. In cases of more severe damage or inflammation, LHBB tenotomy will be performed instead. Acromioclavicular (AC) joint repositioning and vertical stabilization will be performed using a suspensory fixation system with titanium buttons and synthetic tapes.
Other possible procedures include subacromial and subcoracoid bursectomy with soft tissue release, acromioplasty, tuberoplasty, AC joint resection, capsulotomy, synovectomy, microfracture (MFX), paralabral cyst evacuation, tendon drilling, removal of calcifications or implants, and tissue or implant sampling for histological and microbiological analysis. At the beginning of surgery and every 15 minutes thereafter, the surgeon will assess arthroscopic visibility using a Visual Analogue Scale (VAS-V) ranging from 0 (worst) to 10 (best), while being blinded to TXA allocation. Simultaneously, the endoscopic screen will be photographed with a 40 MP camera. Scores will be recorded, and images stored. Screen photos will be presented after surgery to three independent surgeons with experience in arthroscopy on visual clarity estimation (VAS range 0-10). Intraoperative data will include the number and extent of tendon lesions, presence of synovitis, operative time, mean arterial pressure (MAP), number of irrigation pressure boosts, and fluid inflow/outflow volumes. All procedures and implants will be documented. Any intraoperative complications (e.g., camera fogging, implant/instrument failure) will be noted. All administered crystalloids/colloids will be listed. Irrigation waste fluid will be collected and homogenized, and a 20 mL sample will be taken for analysis. Hemoglobin concentration will then be determined in the homogenized sample using spectrophotometry (Cripps method; University of Rijeka, Medical Faculty; Varian Cary 100 Bio, 190-900 nm, resolution ≤ 0.189 nm, wavelength accuracy ± 0.02-0.04 nm). On the first day after the surgery, the shoulder circumference will be measured at 3 typical sites and the level of pain will be noted (VAS range 0 no pain -10 the strongest pain). On the second day, the shoulder circumference measurement and estimation of the level of pain will be repeated. Also blood will be taken from a vein and complete blood count will be repeated. During the postoperative period, the amount and type of analgesic drugs administered and the length of hospitalization will be monitored.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid injectable product | Experimental | Drug: Tranexamic Acid Injectable ProductPatients from the experimental group will receive 10 minutes before the procedure 1 g of tranexamic acid in 100 ml of saline intravenously |
| Placebo | Placebo comparator | Drug: PlaceboPatients from the control group will receive 10 minutes before the procedure 100 ml sterile saline intravenously |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- rotator cuff tear
Key exclusion criteria (11 listed)
- allergy to tranexamic acid, paracetamol (acetaminophen), ketoprofen, tramadol or metamizole sodium
- deep vein thrombosis
- congenital thrombophilia
- coagulopathy
- thromboembolic events within the previous 12 months
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 Acid Injectable ProductPatients from the experimental group will receive 10 minutes before the procedure 1 g of tranexamic acid in 100 ml of saline intravenously unlike the patients in the control group who will receive just sterile saline. | Drug | Tranexamic acid injectable product |
| PlaceboPatients from experimental group will receive 10 minutes before the procedure 1 g of tranexamic acid in 100 ml of saline intravenously unlike the patients in the control group who will receive just sterile saline. | Drug | Placebo |
Primary outcome
Visual Clarity on Endoscope Screen During Shoulder Arthroscopy (Intraoperative)
Time frame: From skin incision to final suture (intraoperative period), assessed every 15 minutes, up to 135 minutes
The operating surgeon evaluated intraoperative visual clarity using the Visual Analog Scale for visibility (VAS-V), ranging from 0 (worst visual clarity) to 10 (best visual clarity), at 15-minute intervals during shoulder arthroscopy. At each assessment time point, the endoscope screen was simultaneously photographed. The surgeon was blinded to group allocation. Visual clarity assessments performed from skin incision up to 135 minutes of surgery were included in the analysis. For each participant, all intraoperative VAS-V measurements within this period were averaged to obtain a single mean intraoperative visibility score. Higher scores indicate better visual clarity.
16 secondary outcomes
Independent Assessor Visibility Rating (VAS)
Time frame: From skin incision to final suture (intraoperative period), up to 135 minutes; image assessments performed after completion of surgery
Interobserver Agreement of Independent Assessors for Arthroscopic Visibility Ratings (VAS)
Time frame: After completion of surgery, following blinded assessment of standardized intraoperative arthroscopic images obtained from skin incision to final suture.
Comparison of Arthroscopic Visibility Ratings Between the Operating Surgeon and Independent Assessors (VAS)
Time frame: From skin incision to final suture (intraoperative period), assessed every 15 minutes, up to 135 minutes; independent image evaluations performed after completion of surgery
Concentration of Hemoglobin in Waste Irrigation Fluid (mg/100 mL)
Time frame: From skin incision to final suture (intraoperative period)
Number of Irrigation Pump Pressure-boost Events
Time frame: From skin incision to final suture (intraoperative period)
Total Irrigation Fluid Volume Used (L)
Time frame: From skin incision to final suture (intraoperative period)
Intraoperative Mean Arterial Pressure (MAP), mmHg
Time frame: From skin incision to final suture (intraoperative period)
Duration of Surgery (Minutes)
Time frame: From skin incision to final suture (intraoperative period)
Intraoperative Blood Loss (mL)
Time frame: From skin incision to final suture (intraoperative period)
Total Perioperative Blood Loss (mL)
Time frame: From preoperative baseline (measured 1 day before surgery) to postoperative day 2
Postoperative (Hidden) Blood Loss (mL)
Time frame: From completion of surgery (final suture) to postoperative day 2
Perioperative Drop in Hemoglobin (g/dL)
Time frame: From preoperative baseline (measured 1 day before surgery) to postoperative day 2
Change in Upper-arm Circumference (cm) as Marker of Swelling
Time frame: From preoperative baseline (measured 1 day before surgery) to postoperative day 2
Postoperative Pain (VAS, 0-10)
Time frame: From postoperative day 1 to postoperative day 2
Total Postoperative Analgesic Consumption (mg)
Time frame: From completion of surgery (final suture) until hospital discharge (postoperative inpatient period), up to 7 days
Length of Hospital Stay (Days)
Time frame: From surgery until hospital discharge (postoperative inpatient period)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31870749Liu YF, Hong CK, Hsu KL, Kuan FC, Chen Y, Yeh ML, Su WR. Intravenous Administration of Tranexamic Acid Significantly Improved Clarity of the Visual Field in Arthroscopic Shoulder Surgery. A Prospective, Double-Blind, and Randomized Controlled Trial. Arthroscopy. 2020 Mar;36(3):640-647. doi: 10.1016/j.arthro.2019.10.020. Epub 2019 Dec 20.
- Background: PubMed 33423986Ersin M, Demirel M, Buget MI, Edipoglu IS, Atalar AC, Ersen A. The effect of intravenous tranexamic acid on visual clarity during arthroscopic rotator cuff repair: A randomized, double-blinded, placebo-controlled pilot study. Acta Orthop Traumatol Turc. 2020 Nov;54(6):572-576. doi: 10.5152/j.aott.2020.19164.
- Background: PubMed 5697326Cripps CM. Rapid method for the estimation of plasma haemoglobin levels. J Clin Pathol. 1968 Jan;21(1):110-2. doi: 10.1136/jcp.21.1.110. No abstract available.
- Background: PubMed 29589496Parker JD, Lim KS, Kieser DC, Woodfield TBF, Hooper GJ. Is tranexamic acid toxic to articular cartilage when administered topically? What is the safe dose? Bone Joint J. 2018 Mar 1;100-B(3):404-412. doi: 10.1302/0301-620X.100B3.BJJ-2017-1135.R1.
- Background: PubMed 32233251Gao HL, Zhang JC, He Y, Zhai WT, Xiao LB, Shi Q. [Clinical study on the control of intra-articular hemorrhage by tranexamic acid after shoulder arthroscopy]. Zhongguo Gu Shang. 2020 Mar 25;33(3):238-41. doi: 10.12200/j.issn.1003-0034.2020.03.010. Chinese.
- Background: PubMed 33463426Bayram E, Yildirim C, Erturk AK, Yilmaz M, Atlihan D. Comparison of the efficacy of irrigation with epinephrine or tranexamic acid on visual clarity during arthroscopic rotator cuff repair: A double-blind, randomized-controlled study. Jt Dis Relat Surg. 2021;32(1):115-121. doi: 10.5606/ehc.2021.78393. Epub 2021 Jan 6.
- Background: PubMed 33475421Hartland AW, Teoh KH, Rashid MS. Clinical Effectiveness of Intraoperative Tranexamic Acid Use in Shoulder Surgery: A Systematic Review and Meta-analysis. Am J Sports Med. 2021 Sep;49(11):3145-3154. doi: 10.1177/0363546520981679. Epub 2021 Jan 21.
- Background: PubMed 33278534Belk JW, McCarty EC, Houck DA, Dragoo JL, Savoie FH, Thon SG. Tranexamic Acid Use in Knee and Shoulder Arthroscopy Leads to Improved Outcomes and Fewer Hemarthrosis-Related Complications: A Systematic Review of Level I and II Studies. Arthroscopy. 2021 Apr;37(4):1323-1333. doi: 10.1016/j.arthro.2020.11.051. Epub 2020 Dec 2.
- Background: PubMed 31990755Rodriguez-Merchan EC. Tranexamic acid is effective in decreasing postoperative intraarticular bleeding in arthroscopic knee surgery. Blood Coagul Fibrinolysis. 2020 Apr;31(3):175-178. doi: 10.1097/MBC.0000000000000895.
- Background: PubMed 28902659Kirsch JM, Bedi A, Horner N, Wiater JM, Pauzenberger L, Koueiter DM, Miller BS, Bhandari M, Khan M. Tranexamic Acid in Shoulder Arthroplasty: A Systematic Review and Meta-Analysis. JBJS Rev. 2017 Sep;5(9):e3. doi: 10.2106/JBJS.RVW.17.00021.
- Background: PubMed 29249226Goldstein M, Feldmann C, Wulf H, Wiesmann T. Tranexamic Acid Prophylaxis in Hip and Knee Joint Replacement. Dtsch Arztebl Int. 2017 Dec 1;114(48):824-830. doi: 10.3238/arztebl.2017.0824.
- Background: PubMed 25797505Ng W, Jerath A, Wasowicz M. Tranexamic acid: a clinical review. Anaesthesiol Intensive Ther. 2015;47(4):339-50. doi: 10.5603/AIT.a2015.0011. Epub 2015 Mar 23.
- Individual participant dataSharing planned: Yes. There will be a limit of access only to patients names
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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.
Nikola Matejcic, MD principal investigator
University orthopaedic and trauma hospital Lovran, Croatia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic Acid Injectable Product in people with Rotator Cuff Tears and Hemorrhage, Surgical, run by Nikola Matejcic at 1 site in Croatia.
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 1 inclusion and 11 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 24 Feb 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 Croatia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Visual Clarity on Endoscope Screen During Shoulder Arthroscopy (Intraoperative) (time frame: From skin incision to final suture (intraoperative period), assessed every 15 minutes, up to 135 minutes). 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 NCT05397652, which also lists 26 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 24 Feb 2026.