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NCT04594408 Clinical Trial

Tranexamic Acid to Improve Arthroscopic Visualization in Shoulder Surgery

Rotator Cuff Tears Clinical Trial

Official title:
The Use of Tranexamic Acid in Irrigation Fluid to Improve Arthroscopic Visualization in Shoulder Surgery: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04594408
Other study ID # PA2018-001
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date September 1, 2020
Est. completion date January 1, 2024

Study information
Verified date April 2024
Source Panam Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine if intravenous TXA is a safe alternative to epinephrine in improving arthroscopic shoulder visualization. Primary Objectives 1. Determine that patients given intravenous tranexamic acid improves surgeon-rated visualization compared to placebo. 2. Determine that intravenous tranexamic acid is a safe alternative to epinephrine mixed irrigation fluid to improve arthroscopic shoulder visualization

Description:

In the last twenty years, the use of arthroscopy to surgically manage shoulder pathologies has expanded in its indications. The interplay between increased indications, surgeon experience, and improvements in equipment have all propelled arthroscopic shoulder surgery to preferred treatment in managing instability, rotator cuff, and impingement pathology. Obtaining adequate visual clarity is paramount to performing the procedures safely, efficiently, and effectively. A variety of methods have been employed to improve visualization. This includes tighter control of blood pressure, regional anesthetic, pressure controlled irrigation system, sealed cannulas, electrocautery devices, and injecting epinephrine into irrigation fluid. The use of epinephrine in irrigation fluid has been studied in literature. The results of a few randomized controlled trials demonstrate that the vasoconstrictive properties of epinephrine decrease blood flow and consequently, improves surgeon visualization. However, there has been reports of ventricular tachycardia, lethal arrhythmias, and epinephrine induced pulmonary edema in literature that suggests that the addition of epinephrine in irrigation fluid may have caused these adverse events. Therefore, it is important to examine other alternatives, such as TXA, that can decrease bleeding and improve visualization without potential detrimental effects. This trial will be conducted in compliance with the protocol, GCP, and the applicable regulatory requirements.

Recruitment information / eligibility
Status Completed
Enrollment 128
Est. completion date January 1, 2024
Est. primary completion date October 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Able to read and understand patient consent form and give informed consent - Rotator cuff pathology or impingement that have clinical indications for shoulder arthroscopy surgery (either rotator cuff repair or subacromial decompression Exclusion Criteria: - Have an active thromboembolic event - Allergies or hypersensitivies to TXA or any of the ingredients - Have a seizure disorder - On hormonal contraceptives - Pregnant - History of venous thromboembolism in the previous 12 months, or requiring lifelong anticoagulation related to previous VTE. VTE is defined as a cerebrovascular event (stroke, transient ischemic attack, deep vein thrombosis, and pulmonary embolism or with a history of hypercoagulable disorders (i.e. Factor V Lieden, antiphospholipid antibody) - Acquired disturbances of colour vision - Hematuria with renal cause

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Epinephrine
1 mL of 1:1000 mixed into irrigation bag.
• Tranexamic acid
1 g IV x 1 dose to be administered intraoperatively.
• Epinephrine and Tranexamic Acid
1 mL of 1:1000 epinephrine mixed into irrigation bag, and 1 g tranexamic acid x 1 dose to be administered intraoperatively.

Locations
Country Name City State
Canada Pan Am Clinic Winnipeg Manitoba

Sponsors (2)
Lead Sponsor Collaborator
Panam Clinic University of Manitoba

Country where clinical trial is conducted

Canada, 

References & Publications (17)

Alshryda S, Sarda P, Sukeik M, Nargol A, Blenkinsopp J, Mason JM. Tranexamic acid in total knee replacement: a systematic review and meta-analysis. J Bone Joint Surg Br. 2011 Dec;93(12):1577-85. doi: 10.1302/0301-620X.93B12.26989. — 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

Benoni G, Fredin H. Fibrinolytic inhibition with tranexamic acid reduces blood loss and blood transfusion after knee arthroplasty: a prospective, randomised, double-blind study of 86 patients. J Bone Joint Surg Br. 1996 May;78(3):434-40. — View Citation

Cho SH, Yi JW, Kwack YH, Park SW, Kim MK, Rhee YG. Ventricular tachycardia during arthroscopic shoulder surgery: a report of two cases. Arch Orthop Trauma Surg. 2010 Mar;130(3):353-6. doi: 10.1007/s00402-009-0820-1. Epub 2009 Jan 29. — View Citation

Huang F, Wu D, Ma G, Yin Z, Wang Q. The use of tranexamic acid to reduce blood loss and transfusion in major orthopedic surgery: a meta-analysis. J Surg Res. 2014 Jan;186(1):318-27. doi: 10.1016/j.jss.2013.08.020. Epub 2013 Sep 13. — 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

Johansson T, Pettersson LG, Lisander B. Tranexamic acid in total hip arthroplasty saves blood and money: a randomized, double-blind study in 100 patients. Acta Orthop. 2005 Jun;76(3):314-9. — View Citation

Karns JL. Epinephrine-induced potentially lethal arrhythmia during arthroscopic shoulder surgery: a case report. AANA J. 1999 Oct;67(5):419-21. — View Citation

Mazzocca AD, Meneghini RM, Chhablani R, Badrinath SK, Cole BJ, Bush-Joseph CA. Epinephrine-induced pulmonary edema during arthroscopic knee surgery. A case report. J Bone Joint Surg Am. 2003 May;85(5):913-5. doi: 10.2106/00004623-200305000-00023. No abstract available. — View Citation

McCormack PL. Tranexamic acid: a review of its use in the treatment of hyperfibrinolysis. Drugs. 2012 Mar 26;72(5):585-617. doi: 10.2165/11209070-000000000-00000. — 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

Ogilvie-Harris DJ, Weisleder L. Fluid pump systems for arthroscopy: a comparison of pressure control versus pressure and flow control. Arthroscopy. 1995 Oct;11(5):591-5. doi: 10.1016/0749-8063(95)90137-x. — View Citation

Sukeik M, Alshryda S, Haddad FS, Mason JM. Systematic review and meta-analysis of the use of tranexamic acid in total hip replacement. J Bone Joint Surg Br. 2011 Jan;93(1):39-46. doi: 10.1302/0301-620X.93B1.24984. — View Citation

Tan J, Chen H, Liu Q, Chen C, Huang W. A meta-analysis of the effectiveness and safety of using tranexamic acid in primary unilateral total knee arthroplasty. J Surg Res. 2013 Oct;184(2):880-7. doi: 10.1016/j.jss.2013.03.099. Epub 2013 Apr 25. — 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

Yang ZG, Chen WP, Wu LD. Effectiveness and safety of tranexamic acid in reducing blood loss in total knee arthroplasty: a meta-analysis. J Bone Joint Surg Am. 2012 Jul 3;94(13):1153-9. doi: 10.2106/JBJS.K.00873. — View Citation

Zhou XD, Tao LJ, Li J, Wu LD. Do we really need tranexamic acid in total hip arthroplasty? A meta-analysis of nineteen randomized controlled trials. Arch Orthop Trauma Surg. 2013 Jul;133(7):1017-27. doi: 10.1007/s00402-013-1761-2. Epub 2013 Apr 25. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome
Type Measure Description Time frame Safety issue
Primary Visualization Quality Scale Surgeons are asked every 15 minutes to report on the quality of visualization based on a 4-point scale. Minimum value is 0, maximum value is 3 with the higher value reflecting improved visualization Intra-operative
Secondary Patient Log Book for Pain and Medications Patients are sent home from surgery with a log book to track the level of pain they are experiencing as well as the medications that they take. Day of surgery - post-operative day 14
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