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| Name | Class |
|---|---|
| University orthopaedic and trauma hospital Lovran | UNKNOWN |
| University of Rijeka | OTHER |
| University of Zagreb, The Faculty of Kinesiology | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Placebo | Placebo Comparator | Patients from the control group will receive 10 minutes before the procedure 100 ml sterile saline intravenously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid Injectable Product | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From skin incision to final suture (intraoperative period), assessed every 15 minutes, up to 135 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
- rotator cuff tear
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nikola Matejcic, MD | University orthopaedic and trauma hospital Lovran, Croatia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University orthopaedic and trauma hospital | Lovran | Primorje-Gorski Kotar County | 51415 | Croatia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31870749 | Background | 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. | |
| 33423986 |
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There will be a limit of access only to patients names
After 1.9.2023 for 3 years
Contact principal investigator
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Of 121 enrolled participants 84 met inclusion criteria and were randomized to treatment
Participants were recruited and enrolled at a single orthopedic center. Recruitment began after institutional ethics approval on May 11, 2021, and continued until approximately June 2022. Eligible patients scheduled for arthroscopic shoulder surgery were screened and consecutively enrolled from May 24, 2021, to July 13, 2022, after meeting eligibility criteria and providing written informed consent.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tranexamic Acid Injectable Product | Patients from the experimental group will receive 10 minutes before the procedure 1 g of tranexamic acid in 100 ml of saline intravenously Tranexamic Acid Injectable Product: 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. |
| FG001 | Placebo | Patients from the control group will receive 10 minutes before the procedure 100 ml sterile saline intravenously Placebo: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tranexamic Acid Injectable Product | Patients from the experimental group will receive 10 minutes before the procedure 1 g of tranexamic acid in 100 ml of saline intravenously Tranexamic Acid Injectable Product: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Visual Analog Scale for visibility (VAS-V), 0 = worst, 10 = best | Posted | Mean | Standard Deviation | units on a scale | From skin incision to final suture (intraoperative period), assessed every 15 minutes, up to 135 minutes |
|
From surgery until hospital discharge (postoperative inpatient period), up to 7 days
No deaths, serious adverse events, or other adverse events were observed during the study period. Adverse events were monitored throughout the intraoperative and postoperative hospital stay.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tranexamic Acid Injectable Product | Patients from the experimental group will receive 10 minutes before the procedure 1 g of tranexamic acid in 100 ml of saline intravenously Tranexamic Acid Injectable Product: 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. |
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The trial was registered after initiation of enrollment. Adverse events were not systematically collected and were recorded only if they occurred during the perioperative hospital stay. Intraoperative visual clarity assessment was subjective; however, it was supported by objective hemoglobin measurements in irrigation fluid and by independent evaluation of intraoperative images by three blinded expert assessors. The study was conducted at a single center.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nikola Matejcic | University orthopaedic and trauma hospital Lovran Croatia | +385959061952 | mat2lovran@yahoo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 22, 2025 | Dec 22, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| D016063 | Blood Loss, Surgical |
| D000070599 | Shoulder Injuries |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D013708 | Tendon Injuries |
| D010335 | Pathologic Processes |
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| Placebo | Drug | 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. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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). | 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. | 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. | 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. | 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. | 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. | 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. | 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. | From surgery until hospital discharge (postoperative inpatient period) |
| Ersin 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. |
| 5697326 | Background | Cripps 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. |
| 29589496 | Background | Parker 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. |
| 32233251 | Background | Gao 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. |
| 33463426 | Background | Bayram 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. |
| 33475421 | Background | Hartland 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. |
| 33278534 | Background | Belk 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. |
| 31990755 | Background | Rodriguez-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. |
| 28902659 | Background | Kirsch 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. |
| 29249226 | Background | Goldstein 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. |
| 25797505 | Background | Ng 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. |
| 26524933 | Background | van 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. |
| 11828349 | Background | Weber 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. |
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| 25442659 | Background | Avery DM 3rd, Gibson BW, Carolan GF. Surgeon-rated visualization in shoulder arthroscopy: a randomized blinded controlled trial comparing irrigation fluid with and without epinephrine. Arthroscopy. 2015 Jan;31(1):12-8. doi: 10.1016/j.arthro.2014.08.010. Epub 2014 Nov 6. |
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| 8089249 | Background | Smith JJ, Porth CM, Erickson M. Hemodynamic response to the upright posture. J Clin Pharmacol. 1994 May;34(5):375-86. doi: 10.1002/j.1552-4604.1994.tb04977.x. |
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| BG001 | Placebo | Patients from the control group will receive 10 minutes before the procedure 100 ml sterile saline intravenously Placebo: 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Patients from the experimental group will receive 10 minutes before the procedure 1 g of tranexamic acid in 100 ml of saline intravenously Tranexamic Acid Injectable Product: 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. |
| OG001 | Placebo | Patients from the control group will receive 10 minutes before the procedure 100 ml sterile saline intravenously Placebo: 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. |
|
|
| Secondary | 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. | All randomized and operated participants with available standardized arthroscopic images were included in the analysis. Three blinded independent assessors evaluated the images using a Visual Analog Scale (VAS) ranging from 0 (worst visibility) to 10 (best visibility). For each participant, visibility ratings from all assessors were averaged to obtain a single mean score. Higher scores indicate better visibility. | Posted | Mean | Standard Deviation | units on a scale | From skin incision to final suture (intraoperative period), up to 135 minutes; image assessments performed after completion of surgery |
|
|
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| Secondary | 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. | All randomized and operated participants with available standardized intraoperative arthroscopic images were included in the analysis. Interobserver agreement was calculated across all images evaluated by the three blinded assessors; therefore, a single Cronbach's alpha coefficient is reported for both study arms. | Posted | Number | alpha coefficient | After completion of surgery, following blinded assessment of standardized intraoperative arthroscopic images obtained from skin incision to final suture. |
|
|
|
| Secondary | 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. | All randomized and operated participants with available intraoperative surgeon ratings and corresponding standardized arthroscopic images evaluated by independent assessors were included in the analysis. | Posted | Mean | Standard Deviation | units on a scale | From skin incision to final suture (intraoperative period), assessed every 15 minutes, up to 135 minutes; independent image evaluations performed after completion of surgery |
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| Secondary | 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. | All randomized and operated participants with available waste irrigation fluid samples were included in the analysis. | Posted | Mean | Standard Deviation | mg/100ml | From skin incision to final suture (intraoperative period) |
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| Secondary | 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. | All randomized and operated participants with available intraoperative arthroscopic pump pressure data were included in the analysis. For each participant, the total number of pressure-boost events recorded during the intraoperative period was analyzed. | Posted | Mean | Standard Deviation | events | From skin incision to final suture (intraoperative period) |
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| Secondary | 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. | All randomized and operated participants with available intraoperative irrigation fluid volume data were included in the analysis. | Posted | Mean | Standard Deviation | L | From skin incision to final suture (intraoperative period) |
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| Secondary | 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. | All randomized and operated participants with available intraoperative anesthesia monitoring data were included in the analysis | Posted | Mean | Standard Deviation | mmHg | From skin incision to final suture (intraoperative period) |
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| Secondary | 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. | All randomized and operated participants with recorded operative times were included in the analysis. | Posted | Mean | Standard Deviation | minutes | From skin incision to final suture (intraoperative period) |
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| Secondary | 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). | All randomized and operated participants with available waste irrigation fluid hemoglobin data were included in the analysis. | Posted | Mean | Standard Deviation | mL | From skin incision to final suture (intraoperative period) |
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| Secondary | 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. | All randomized and operated participants with available perioperative hematocrit measurements were included in the analysis. | Posted | Mean | Standard Deviation | mL | From preoperative baseline (measured 1 day before surgery) to postoperative day 2 |
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| Secondary | Postoperative (Hidden) Blood Loss (mL) | Postoperative (hidden) blood loss was calculated by subtracting the intraoperative blood loss from the total perioperative blood loss. | All randomized and operated participants with available perioperative blood loss data were included in the analysis. | Posted | Mean | Standard Deviation | mL | From completion of surgery (final suture) to postoperative day 2 |
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| Secondary | 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. | All randomized and operated participants with available perioperative hemoglobin measurements were included in the analysis. | Posted | Mean | Standard Deviation | g/dl | From preoperative baseline (measured 1 day before surgery) to postoperative day 2 |
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| Secondary | 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. | All randomized and operated participants with available upper-arm circumference measurements at baseline and postoperative day 2 were included in the analysis. | Posted | Mean | Standard Deviation | cm | From preoperative baseline (measured 1 day before surgery) to postoperative day 2 |
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| Secondary | 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. | All randomized and operated participants with available postoperative pain assessments were included in the analysis | Posted | Mean | Standard Deviation | units on a scale | From postoperative day 1 to postoperative day 2 |
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| Secondary | 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. | All randomized and operated participants with recorded postoperative analgesic administration were included in the analysis. | Posted | Mean | Standard Deviation | mg | From completion of surgery (final suture) until hospital discharge (postoperative inpatient period), up to 7 days |
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| Secondary | 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. | All randomized and operated participants with recorded postoperative hospital stay were included in the analysis. | Posted | Mean | Standard Deviation | days | From surgery until hospital discharge (postoperative inpatient period) |
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| 0 |
| 43 |
| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | Placebo | Patients from the control group will receive 10 minutes before the procedure 100 ml sterile saline intravenously Placebo: 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. | 0 | 41 | 0 | 41 | 0 | 41 |
Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D007431 | Intraoperative Complications |