Effect of Intravenous Tranexamic Acid on Visual Clarity During Shoulder Arthroscopy in the Beach Chair Position

NCT05397652 | Completed Phase 4 Results DMC

• 1 other identifier: MATTXA2022
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Hemorrhage, Surgical; Shoulder Injuries; Rotator Cuff Tears

Keywords

Arthroscopy; Hemorrhage; Shoulder; Tranexamic acid

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (16)

• Independent Assessor Visibility Rating (VAS)

  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)

  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)

  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)

  From skin incision to final suture (intraoperative period)

• Number of Irrigation Pump Pressure-boost Events

  From skin incision to final suture (intraoperative period)

Study Arms (2)

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

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

Drug: Placebo

Interventions

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.

Placebo

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.

Tranexamic acid injectable product

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- rotator cuff tear

You may not qualify if:

• 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
• renal failure
• liver cirrhosis
• glaucoma or retinal vascular disorder
• chronic treatment with anticoagulant or antiplatelet therapy
• uncontrolled hypertension (systolic blood pressure \> 180 mmHg)

Sponsors & Collaborators

• Nikola Matejcic: lead
• University orthopaedic and trauma hospital Lovran: collaborator
• University of Rijeka, The Faculty of Medicine: collaborator
• University of Zagreb, The Faculty of Kinesiology: collaborator

Study Sites (1)

University orthopaedic and trauma hospital

Lovran, Primorje-Gorski Kotar County, 51415, Croatia

Location

Related Publications (26)

• 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.

  PMID: 31870749 BACKGROUND

• 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.

  PMID: 33423986 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.

  PMID: 5697326 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.

  PMID: 29589496 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.

  PMID: 32233251 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.

  PMID: 33463426 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.

  PMID: 33475421 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.

  PMID: 33278534 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.

  PMID: 31990755 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.

  PMID: 28902659 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.

  PMID: 29249226 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.

  PMID: 25797505 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.

  PMID: 26524933 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.

  PMID: 11828349 BACKGROUND

• Memon 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.

  PMID: 29785406 BACKGROUND

• Rains DD, Rooke GA, Wahl CJ. Pathomechanisms and complications related to patient positioning and anesthesia during shoulder arthroscopy. Arthroscopy. 2011 Apr;27(4):532-41. doi: 10.1016/j.arthro.2010.09.008. Epub 2010 Dec 24.

  PMID: 21186092 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.

  PMID: 25442659 BACKGROUND

• Nho SJ, Freedman KB, Bansal SL, Romeo AA, Bach BR Jr, Bush-Joseph CA, Turner DA, Cole BJ. The effect of radiofrequency energy on nonweight-bearing areas of bone following shoulder and knee arthroscopy. Orthopedics. 2005 Apr;28(4):392-9. doi: 10.3928/0147-7447-20050401-16.

  PMID: 15887586 BACKGROUND

• Tuijthof GJ, de Vaal MM, Sierevelt IN, Blankevoort L, van der List MP. Performance of arthroscopic irrigation systems assessed with automatic blood detection. Knee Surg Sports Traumatol Arthrosc. 2011 Nov;19(11):1948-54. doi: 10.1007/s00167-011-1495-z. Epub 2011 Apr 9.

  PMID: 21479643 BACKGROUND

• Tuijthof GJ, Dusee L, Herder JL, van Dijk CN, Pistecky PV. Behavior of arthroscopic irrigation systems. Knee Surg Sports Traumatol Arthrosc. 2005 Apr;13(3):238-46. doi: 10.1007/s00167-004-0573-x. Epub 2005 Jan 4.

  PMID: 15630604 BACKGROUND

• Burkhart SS, Danaceau SM, Athanasiou KA. Turbulence control as a factor in improving visualization during subacromial shoulder arthroscopy. Arthroscopy. 2001 Feb;17(2):209-12. doi: 10.1053/jars.2001.22298.

  PMID: 11172254 BACKGROUND

• Ampat G, Bruguera J, Copeland SA. Aquaflo pump vs FMS 4 pump for shoulder arthroscopic surgery. Ann R Coll Surg Engl. 1997 Sep;79(5):341-4.

  PMID: 9326125 BACKGROUND

• Morrison DS, Schaefer RK, Friedman RL. The relationship between subacromial space pressure, blood pressure, and visual clarity during arthroscopic subacromial decompression. Arthroscopy. 1995 Oct;11(5):557-60. doi: 10.1016/0749-8063(95)90131-0.

  PMID: 8534296 BACKGROUND

• Jensen KH, Werther K, Stryger V, Schultz K, Falkenberg B. Arthroscopic shoulder surgery with epinephrine saline irrigation. Arthroscopy. 2001 Jul;17(6):578-81. doi: 10.1053/jars.2001.23590.

  PMID: 11447543 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.

  PMID: 8089249 BACKGROUND

• Li X, Eichinger JK, Hartshorn T, Zhou H, Matzkin EG, Warner JP. A comparison of the lateral decubitus and beach-chair positions for shoulder surgery: advantages and complications. J Am Acad Orthop Surg. 2015 Jan;23(1):18-28. doi: 10.5435/JAAOS-23-01-18.

  PMID: 25538127 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries; Blood Loss, Surgical; Shoulder Injuries; Hemorrhage

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Tendon Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Limitations and Caveats

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.

Results Point of Contact

• Title: Nikola Matejcic
• Organization: University orthopaedic and trauma hospital Lovran Croatia

mat2lovran@yahoo.com

+385959061952

Study Officials

• Nikola Matejcic, MD

  University orthopaedic and trauma hospital Lovran, Croatia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 31, 2022
• Study Start: May 24, 2021
• Primary Completion: July 21, 2023
• Study Completion: July 21, 2023
• Last Updated: February 24, 2026
• Results First Posted: February 24, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After 1.9.2023 for 3 years
• Access Criteria: Contact principal investigator

Locations

CR (1)