Rotator Cuff TearsPhase 3NCT04865380
Does Tranexamic Acid Improve Visualization During Arthroscopic Rotator Cuff Repair
A Phase 3 study testing Tranexamic Acid 100 MG/ML in people with Rotator Cuff Tears and Rotator Cuff Injuries, run by University of Saskatchewan at 1 site in Canada.
Trial summary
This clinical trial examines whether intravenous preoperative administration of tranexamic acid (TXA) before arthroscopic rotator cuff repair (ARCR) can improve arthroscopic visualization during the procedure. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Rotator Cuff Tears, Rotator Cuff Injuries, Subacromial Impingement
- What is being tested?
- Tranexamic Acid 100 MG/ML
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 13 Jan 2021to Apr 2022
- Phase
- Phase 3
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-100
- Male and Female
- Patient able to read and understand consent form
- Non-traumatic, simple small or medium sized rotator cuff tear as defined by pre-operative MRI
- Booked to operating room for elective rotator cuff repair
- Beach chair positioning
Who cannot join
- Patient refusal to participate
- Massive rotator cuff tear
- Acute traumatic rotator cuff tear
- Known coagulopathy
- Patients with a history or risk of thromboembolism
- Known hypersensitivity to tranexamic acid
Show all 19Show fewer
- Patient unable to be off anti-coagulant medication for long enough to counter effects
- Patient has a clinic systolic blood pressure > 150mmHg
- Lateral positioning
- Requirement or insistence by patient or anesthesiologist on regional block
- Patients who have smoked nicotine products within the last year
- The presence of other inflammatory conditions (calcific tendonitis, rheumatoid arthritis, etc.)
- The presence of active thromboembolic disease, such as deep vein thrombosis, pulmonary embolism, and cerebral thrombosis
- Patient has a seizure disorder
- Patients on medications identified as having drug-drug interactions (hormonal contraceptive, hydrochlorothiazide, desmopressin, sulbactam-ampicilllin, carbazochrome, ranitidine, or nitroglycerine
- Patient is pregnant
- Patients with history of subarachnoid hemorrhage
- Patients with renal insufficiency
- Patients with acquired disturbances of color vision
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Dash & Reed Sports Medicine
White City, Saskatchewan, S4L 5B1
Jeremy Reed, MD, 3065664660, jreed@usask.ca
Jeremy Reed, MD
About this study
Official title: Does Tranexamic Acid Improve Visualization During Arthroscopic Rotator Cuff Repair: A Double Blinded, Randomized Control Trial
This clinical trial examines whether intravenous preoperative administration of tranexamic acid (TXA) before arthroscopic rotator cuff repair (ARCR) can improve arthroscopic visualization during the procedure.
- Conditions
- Rotator Cuff Tears, Rotator Cuff Injuries, Subacromial Impingement, Subacromial Impingement Syndrome
- Being tested
- Tranexamic Acid 100 MG/ML
- 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.
Tranexamic Acid 100 MG/MLDrug
Also called Sandoz Tranexamic Acid Injection BP 100mg/mL, DIN 02246365
1g IV x 1 dose of Tranexamic Acid administered preoperatively.
| Study group | Role | What they receive |
|---|---|---|
| No Tranexamic Acid | No intervention | The anesthesiologist will not administer Tranexamic Acid at any point. |
| Intravenous Tranexamic Acid | Experimental | 1g of Tranexamic Acid will be administered intravenously prior to the start of the operation. Receives: Drug: Tranexamic Acid 100 MG/ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arthroscopic Visualization Score
A visualization score from 1 to 6 assessed by the surgeon.
- - Perfect visualization
- - Mild difficulty that could easily be worked around
- - Moderate difficulty that required modifications to the surgical plan
- - Significant difficulty that added more than 10 minutes to the case
- - Major difficulty that added more than 20 minutes to the case
- - Difficulty that forced the stoppage of the case
Measured: Surgeon will complete the visualization score immediately after the surgery is completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start13 Jan 2021
- Primary completionDec 2021 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Reed, University of Saskatchewan
- Investigators
- Jeremy Reed, MD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04865380
- Sponsor's protocol ID
- BIO-1983
- Status last verified
- Apr 2021
- First submitted
- 26 Apr 2021
- Last updated
- 3 May 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Tranexamic Acid Improve Visualization During Arthroscopic Rotator Cuff Repair: A Double Blinded, Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04865380
- Acronym / sponsor ID
- BIO-1983
- Conditions
- Rotator Cuff Tears, Rotator Cuff Injuries, Subacromial Impingement, Subacromial Impingement Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 29 Apr 2021 (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.
This clinical trial examines whether intravenous preoperative administration of tranexamic acid (TXA) before arthroscopic rotator cuff repair (ARCR) can improve arthroscopic visualization during the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Tranexamic Acid | No intervention | –The anesthesiologist will not administer Tranexamic Acid at any point. |
| Intravenous Tranexamic Acid | Experimental | Drug: Tranexamic Acid 100 MG/ML1g of Tranexamic Acid will be administered intravenously prior to the start of the operation. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-100
- Male and Female
- Patient able to read and understand consent form
- Non-traumatic, simple small or medium sized rotator cuff tear as defined by pre-operative MRI
- Booked to operating room for elective rotator cuff repair
Key exclusion criteria (19 listed)
- Patient refusal to participate
- Massive rotator cuff tear
- Acute traumatic rotator cuff tear
- Known coagulopathy
- Patients with a history or risk of thromboembolism
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 |
|---|---|---|
| Tranexamic Acid 100 MG/MLAlso: Sandoz Tranexamic Acid Injection BP 100mg/mL, DIN 022463651g IV x 1 dose of Tranexamic Acid administered preoperatively. | Drug | Intravenous Tranexamic Acid |
Primary outcome
Arthroscopic Visualization Score
Time frame: Surgeon will complete the visualization score immediately after the surgery is completed.
A visualization score from 1 to 6 assessed by the surgeon. 1. - Perfect visualization 2. - Mild difficulty that could easily be worked around 3. - Moderate difficulty that required modifications to the surgical plan 4. - Significant difficulty that added more than 10 minutes to the case 5. - Major difficulty that added more than 20 minutes to the case 6. - Difficulty that forced the stoppage of the case
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Individual participant dataSharing planned: No
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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.
Jeremy Reed, MD principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tranexamic Acid 100 MG/ML in people with Rotator Cuff Tears and Rotator Cuff Injuries, run by University of Saskatchewan 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 6 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 3 May 2021. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jeremy Reed, MD (3065664660, jreed@usask.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arthroscopic Visualization Score (time frame: Surgeon will complete the visualization score immediately after the surgery is completed.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 May 2021.