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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05397652
Other study ID # MATTXA2022
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date May 24, 2021
Est. completion date July 21, 2023

Study information

Verified date July 2023
Source Clinic for Orthopedics Lovran
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Shoulder arthroscopy provides many benefits with a permanent increase in the possibilities and complexity of the application. A condition to perform it is intraoperative visual clarity dependent on hemorrhage control. The aim of this prospective, double blind, randomized, and controlled study is to examine the effect of intravenously administered tranexamic acid (TXA) on the visual clarity, perioperative hemorrhage, duration and early postoperative course of shoulder arthroscopy in beach chair position, which is not yet available in the literature. In the tested and control group, the investigators measure hemoglobin (Hb) in the waste irrigation fluid and the patient's blood before and after the procedure, visual clarity, duration of the procedure, postoperative shoulder swelling, pain level and analgesic drug consumption. The research uses scientific methods to determine if there is a reasonable basis for introducing TXA into routine clinical use.


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. 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 tranexamic acid 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 2-3 kg. All patients will be operated on by the same surgeon (NM) with the usual equipment: 4.5 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. Tendon reconstructions and shoulder stabilization will be performed in the usual way with suture anchors. During the procedure, the visual clarity on the endoscope screen (Visual analog scale VAS range: 0 worst visual clarity - 10 best visual clarity) will be evaluated by the surgeon every 15 minutes and the screen will be photographed at the same time. Screen photos will be presented after surgery to three independent surgeons with experience in arthroscopy on visual clarity estimation (VAS range 0-10). During the procedure, the number of times the pump pressure is increased will be counted. At the end of the surgery, the mean arterial pressure (MAP) will be noted, the exact amount of irrigation fluid consumed and the duration of the procedure from the first incision to the last skin suture will be calculated. A homogenized sample will be taken from the total volume of the waste solution in which the Hb concentration will be determined by a spectrophotometer using the Cripps method (University of Rijeka, Medical Faculty; spectrophotometer Varian Cary 100 Bio 190-900 nm, resolution ≤ 0.189 nm, wavelength accuracy of ± 0.02 nm to ± 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.


Recruitment information / eligibility

Status Completed
Enrollment 104
Est. completion date July 21, 2023
Est. primary completion date July 21, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - rotator cuff tear - instability of the glenohumeral joint - instability of the acromioclavicular joint Exclusion Criteria: - allergy to tranexamic acid - deep vein thrombosis - congenital thrombophilia - coagulopathy - thromboembolic events last 12 months - stroke or acute coronary syndrome last 3 months - renal failure - cirrhosis of the liver - glaucoma or retinal vascular disorder - chronic treatment with anticoagulant therapy - uncontrolled hypertension

Study Design


Intervention

Drug:
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.
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.

Locations

Country Name City State
Croatia University orthopaedic and trauma hospital Lovran Primorsko Goranska

Sponsors (4)

Lead Sponsor Collaborator
Nikola Matejcic University of Rijeka, The Faculty of Medicine, University of Zagreb, The Faculty of Kinesiology, University orthopaedic and trauma hospital Lovran

Country where clinical trial is conducted

Croatia, 

References & Publications (26)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 26 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Visual clarity on endoscope screen during shoulder arthroscopy The surgeon will evaluate visual clarity using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) every 15 minutes during shoulder arthroscopy and screen will be photographed at the same time At the very beginning of the shoulder arthroscopy
Primary Visual clarity on endoscope screen during shoulder arthroscopy The surgeon will evaluate visual clarity using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) every 15 minutes during shoulder arthroscopy and screen will be photographed at the same time After 15 minutes since the beginning of the surgery
Primary Visual clarity on endoscope screen during shoulder arthroscopy The surgeon will evaluate visual clarity using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) every 15 minutes during shoulder arthroscopy and screen will be photographed at the same time After 30 minutes since the beginning of the surgery
Primary Visual clarity on endoscope screen during shoulder arthroscopy The surgeon will evaluate visual clarity using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) every 15 minutes during shoulder arthroscopy and screen will be photographed at the same time After 45 minutes since the beginning of the surgery
Primary Visual clarity on endoscope screen during shoulder arthroscopy The surgeon will evaluate visual clarity using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) every 15 minutes during shoulder arthroscopy and screen will be photographed at the same time After 60 minutes since the beginning of the surgery
Primary Visual clarity on endoscope screen during shoulder arthroscopy The surgeon will evaluate visual clarity using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) every 15 minutes during shoulder arthroscopy and screen will be photographed at the same time After 75 minutes since the beginning of the surgery
Primary Visual clarity on endoscope screen during shoulder arthroscopy The surgeon will evaluate visual clarity using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) every 15 minutes during shoulder arthroscopy and screen will be photographed at the same time After 90 minutes since the beginning of the surgery
Primary Visual clarity on endoscope screen during shoulder arthroscopy The surgeon will evaluate visual clarity using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) every 15 minutes during shoulder arthroscopy and screen will be photographed at the same time After 105 minutes since the beginning of the surgery
Primary Visual clarity on endoscope screen during shoulder arthroscopy The surgeon will evaluate visual clarity using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) every 15 minutes during shoulder arthroscopy and screen will be photographed at the same time After 120 minutes since the beginning of the surgery
Primary Visual clarity on endoscope screen during shoulder arthroscopy The surgeon will evaluate visual clarity using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) every 15 minutes during shoulder arthroscopy and screen will be photographed at the same time After 135 minutes since the beginning of the surgery
Primary Visual clarity on endoscope screen during shoulder arthroscopy The surgeon will evaluate visual clarity using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) every 15 minutes during shoulder arthroscopy and screen will be photographed at the same time After 150 minutes since the beginning of the surgery
Primary Visual clarity on endoscope screen during shoulder arthroscopy Screen photos taken every 15 minutes during shoulder arthroscopy will be presented after surgery to three independent surgeons with experience in arthroscopy on visual clarity estimation using Visual analog scale range from 0 (worst visual clarity) -10 (best visual clarity) Through study completion, an average of 1 year
Primary Perioperative blood loss The investigators will measure hemoglobin (Hb mg/100 mL) in the waste irrigation fluid collected during the surgery Right after the surgery
Primary Perioperative blood loss The investigators will measure hemoglobin (Hb g/L) in the patient's blood before and after the procedure 1 day before the surgery
Primary Perioperative blood loss The investigators will measure hemoglobin (Hb g/L) in the patient's blood before and after the procedure 2nd day after the surgery
Primary Early postoperative course of shoulder arthroscopy The investigators will measure postoperative shoulder swelling. Shoulder circumference will be measured in centimeters (cm) at 3 typical sites one day before the surgery and 1st and 2nd day after the surgery One day before the surgery
Primary Early postoperative course of shoulder arthroscopy The investigators will measure postoperative shoulder swelling. Shoulder circumference will be measured in centimeters (cm) at 3 typical sites one day before the surgery and 1st and 2nd day after the surgery 1st day after the surgery
Primary Early postoperative course of shoulder arthroscopy The investigators will measure postoperative shoulder swelling. Shoulder circumference will be measured in centimeters (cm) at 3 typical sites one day before the surgery and 1st and 2nd day after the surgery 2nd day after the surgery
Primary Early postoperative course of shoulder arthroscopy The investigators will measure postoperative pain level with Visual analog scale range from 0 (no pain) - 10 (the strongest pain) 1st postoperative day
Primary Early postoperative course of shoulder arthroscopy The investigators will measure postoperative pain level with Visual analog scale range from 0 (no pain) - 10 (the strongest pain) 2nd postoperative day
Primary Early postoperative course of shoulder arthroscopy The investigators will measure analgesic drug consumption (mg of peroral or injectable product of paracetamol) During hospitalization (up to 7 days)
Primary Early postoperative course of shoulder arthroscopy The investigators will measure analgesic drug consumption (mg of peroral or injectable product of ketoprofen) During hospitalization (up to 7 days)
Primary Early postoperative course of shoulder arthroscopy The investigators will measure analgesic drug consumption (mg of injectable product of metamizole) During hospitalization (up to 7 days)
Primary Early postoperative course of shoulder arthroscopy The investigators will measure analgesic drug consumption (mg of injectable product of tramadol) During hospitalization (up to 7 days)
Secondary Difference in blood loss between different indications for performing shoulder arthroscopy The investigators will measure hemoglobin (Hb mg/100 mL) in the waste irrigation fluid collected during the different types of shoulder arthroscopy Right after the surgery
Secondary Difference in blood loss between different indications for performing shoulder arthroscopy The investigators will measure hemoglobin (Hb g/L) in the patient's blood before and after the different types of shoulder arthroscopy 1 day before the surgery
Secondary Difference in blood loss between different indications for performing shoulder arthroscopy The investigators will measure hemoglobin (Hb g/L) in the patient's blood before and after the different types of shoulder arthroscopy 2nd day after the surgery
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