Tranexamic Acid to Improve Arthroscopic Visualization in Shoulder Surgery

NCT04594408 | Completed Phase 4 FDA Drug

• 1 other identifier: PA2018-001
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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. 1.Determine that patients given intravenous tranexamic acid improves surgeon-rated visualization compared to placebo.
2. 2.Determine that intravenous tranexamic acid is a safe alternative to epinephrine mixed irrigation fluid to improve arthroscopic shoulder visualization

Conditions

Rotator Cuff Injuries; Rotator Cuff Tears; Subacromial Impingement; Subacromial Impingement Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient Log Book for Pain and Medications

  Day of surgery - post-operative day 14

Study Arms (4)

No epinephrine or TXA

NO INTERVENTION

No intervention given.

Epinephrine in irrigation fluid

ACTIVE COMPARATOR

Epinephrine intervention used.

Drug: Epinephrine

Intravenous TXA

EXPERIMENTAL

Tranexamic acid intervention used.

Drug: Tranexamic acid

Epinephrine and TXA

EXPERIMENTAL

Epinephrine and tranexamic acid intervention used.

Drug: Epinephrine and Tranexamic Acid

Interventions

Epinephrine DRUG

1 mL of 1:1000 mixed into irrigation bag.

Also known as: Epi

Epinephrine in irrigation fluid

Tranexamic acid DRUG

1 g IV x 1 dose to be administered intraoperatively.

Also known as: TXA

Intravenous TXA

Epinephrine and Tranexamic Acid DRUG

1 mL of 1:1000 epinephrine mixed into irrigation bag, and 1 g tranexamic acid x 1 dose to be administered intraoperatively.

Also known as: TXA, Epi

Epinephrine and TXA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Panam Clinic: lead
• University of Manitoba: collaborator

Study Sites (1)

Pan Am Clinic

Winnipeg, Manitoba, R3M 3E4, Canada

Location

Related Publications (17)

• 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

• 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

• 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.

  PMID: 8534302 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

• 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

• 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.

  PMID: 12728044 BACKGROUND

• 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.

  PMID: 19184069 BACKGROUND

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

  PMID: 10876433 BACKGROUND

• 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.

  PMID: 22397329 BACKGROUND

• 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.

  PMID: 16156456 BACKGROUND

• 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.

  PMID: 8636182 BACKGROUND

• 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.

  PMID: 22623147 BACKGROUND

• 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.

  PMID: 23615973 BACKGROUND

• 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.

  PMID: 22161917 BACKGROUND

• 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.

  PMID: 24075404 BACKGROUND

• 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.

  PMID: 21196541 BACKGROUND

• 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.

  PMID: 23643299 BACKGROUND

MeSH Terms

Conditions

Rotator Cuff Injuries; Shoulder Impingement Syndrome

Interventions

Epinephrine; Tranexamic Acid

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Jason Old, MD, FRCSC

  Pan Am Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Surgeons are blinded to group allocation as all IV bags will have labels appearing identical when turned away from the surgeon. Anesthetists are told not to reveal allocation to the surgeon as well. And patients will not be informed of their allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 20, 2020
• Study Start: September 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: January 1, 2024
• Last Updated: April 2, 2024

Record last verified: 2024-04

Locations

CA (1)