Rotator Cuff InjuriesPhase 4NCT04594408
Tranexamic Acid to Improve Arthroscopic Visualization in Shoulder Surgery
A Phase 4 study testing Epinephrine, Tranexamic acid and Epinephrine and Tranexamic Acid in people with Rotator Cuff Injuries and Rotator Cuff Tears, run by Panam Clinic at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Injuries, Rotator Cuff Tears, Subacromial Impingement
- What is being tested?
- Epinephrine, Tranexamic acid and Epinephrine and Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2020to 1 Jan 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Tranexamic Acid in Irrigation Fluid to Improve Arthroscopic Visualization in Shoulder Surgery: A Randomized Controlled Trial
The purpose of this study is to determine if intravenous TXA is a safe alternative to epinephrine in improving arthroscopic shoulder visualization.
Primary Objectives
- Determine that patients given intravenous tranexamic acid improves surgeon-rated visualization compared to placebo.
- Determine that intravenous tranexamic acid is a safe alternative to epinephrine mixed irrigation fluid to improve arthroscopic shoulder visualization
Read the detailed 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.
- Conditions
- Rotator Cuff Injuries, Rotator Cuff Tears, Subacromial Impingement, Subacromial Impingement Syndrome
- Being tested
- Epinephrine, Tranexamic acid, Epinephrine and Tranexamic Acid
- Medical subject headings
- Rotator Cuff Injuries, Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpinephrineDrug
Also called Epi
1 mL of 1:1000 mixed into irrigation bag.
Tranexamic acidDrug
Also called TXA
1 g IV x 1 dose to be administered intraoperatively.
Epinephrine and Tranexamic AcidDrug
Also called TXA, Epi
1 mL of 1:1000 epinephrine mixed into irrigation bag, and 1 g tranexamic acid x 1 dose to be administered intraoperatively.
| Study group | Role | What they receive |
|---|---|---|
| No epinephrine or TXA | No intervention | No intervention given. |
| Epinephrine in irrigation fluid | Active comparator | Epinephrine intervention used. Receives: Drug: Epinephrine |
| Intravenous TXA | Experimental | Tranexamic acid intervention used. Receives: Drug: Tranexamic acid |
| Epinephrine and TXA | Experimental | Epinephrine and tranexamic acid intervention used. Receives: Drug: Epinephrine and Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Intra-operative
Secondary outcomes (1)
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.
Measured: Day of surgery - post-operative day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start1 Sep 2020
- Primary completion1 Oct 2021
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Panam Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- University of Manitoba
- Responsible party
- Sponsor
- Investigators
- Jason Old, MD, FRCSC, Principal investigator, Pan Am Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594408
- Sponsor's protocol ID
- PA2018-001
- Status last verified
- Apr 2024
- First submitted
- 13 Oct 2020
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 11447543Morrison 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.
PubMed 8534296Ogilvie-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.
PubMed 8534302Avery 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.
PubMed 25442659van 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.
PubMed 26524933Mazzocca 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.
PubMed 12728044Cho 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.
PubMed 19184069Karns JL. Epinephrine-induced potentially lethal arrhythmia during arthroscopic shoulder surgery: a case report. AANA J. 1999 Oct;67(5):419-21.
PubMed 10876433McCormack 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.
PubMed 22397329Johansson 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.
PubMed 16156456Benoni 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.
PubMed 8636182Yang 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.
PubMed 22623147Zhou 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.
PubMed 23615973Alshryda 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.
PubMed 22161917Huang 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.
PubMed 24075404
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Tranexamic Acid in Irrigation Fluid to Improve Arthroscopic Visualization in Shoulder Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04594408
- Acronym / sponsor ID
- PA2018-001
- Conditions
- Rotator Cuff Injuries, Rotator Cuff Tears, Subacromial Impingement, Subacromial Impingement Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Panam ClinicUniversity, hospital or other
- Collaborators
- University of Manitoba
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if intravenous TXA is a safe alternative to epinephrine in improving arthroscopic shoulder visualization.
Primary Objectives
- Determine that patients given intravenous tranexamic acid improves surgeon-rated visualization compared to placebo.
- Determine that intravenous tranexamic acid is a safe alternative to epinephrine mixed irrigation fluid to improve arthroscopic shoulder visualization
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No epinephrine or TXA | No intervention | –No intervention given. |
| Epinephrine in irrigation fluid | Active comparator | Drug: EpinephrineEpinephrine intervention used. |
| Intravenous TXA | Experimental | Drug: Tranexamic acidTranexamic acid intervention used. |
| Epinephrine and TXA | Experimental | Drug: Epinephrine and Tranexamic AcidEpinephrine and tranexamic acid intervention used. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- Have an active thromboembolic event
- Allergies or hypersensitivies to TXA or any of the ingredients
- Have a seizure disorder
- On hormonal contraceptives
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpinephrineAlso: Epi1 mL of 1:1000 mixed into irrigation bag. | Drug | Epinephrine in irrigation fluid |
| Tranexamic acidAlso: TXA1 g IV x 1 dose to be administered intraoperatively. | Drug | Intravenous TXA |
| Epinephrine and Tranexamic AcidAlso: TXA, Epi1 mL of 1:1000 epinephrine mixed into irrigation bag, and 1 g tranexamic acid x 1 dose to be administered intraoperatively. | Drug | Epinephrine and TXA |
Primary outcome
Visualization Quality Scale
Time frame: Intra-operative
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
1 secondary outcome
Patient Log Book for Pain and Medications
Time frame: Day of surgery - post-operative day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
- Background: PubMed 11447543Jensen 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.
- Background: PubMed 8534296Morrison 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.
- Background: PubMed 8534302Ogilvie-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.
- Background: PubMed 25442659Avery 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.
- Background: PubMed 26524933van 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.
- Background: PubMed 12728044Mazzocca 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.
- Background: PubMed 19184069Cho 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.
- Background: PubMed 10876433Karns JL. Epinephrine-induced potentially lethal arrhythmia during arthroscopic shoulder surgery: a case report. AANA J. 1999 Oct;67(5):419-21.
- Background: PubMed 22397329McCormack 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.
- Background: PubMed 16156456Johansson 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.
- Background: PubMed 8636182Benoni 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.
- Background: PubMed 22623147Yang 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.
Related trials for Rotator Cuff Injuries
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Active, not recruiting
BioBrace® Implant for Arthroscopic Repair of Full Thickness Rotator Cuff Tears
Rotator Cuff Tears
RecruitingObservational study
Nociplastic Pain in Patients Diagnosed With Subacromial Pain Syndrome (SAPS)
Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain
RecruitingObservational study
Pain Phenotype and Response to Corticosteroid Injection in Patients With Subacromial Pain Syndrome (SAPS)
Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Old, MD, FRCSC principal investigator
Pan Am Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Epinephrine, Tranexamic acid and Epinephrine and Tranexamic Acid in people with Rotator Cuff Injuries and Rotator Cuff Tears, run by Panam Clinic at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visualization Quality Scale (time frame: Intra-operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04594408, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.