Rotator Cuff TearsNCT04628676
Comparison of the Efficacy of Irrigation With Epinephrine or Tranexamic Acid on Visual Clarity
A study testing tranexamic acid and Epinephrine in people with Rotator Cuff Tears, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this report is to determine whether there is a difference between Epinephrine and Tranexamic acid in providing visual clarity during arthroscopic rotator cuff tear repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tears
- What is being tested?
- tranexamic acid and Epinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2017to 30 Jan 2020
- Phase
- Interventional
- 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
- • Age > 18 years
- American Society of Anesthesiologist Physical Status Classification System : 1-2
- Undergoing a full arthroscopic double-row repair due to full-thickness cuff tear
- Being willing to participate the study
Who cannot join
- • Age < 18 years
- American Society of Anesthesiologist Physical Status Classification System ≥3
- Concomitant cardiac diseases
- Concomitant bleeding disorder or coagulopathy
- Diabetes mellitus
- Being pregnant
Show all 11Show fewer
- Use of contraceptive pills
- A history of previous shoulder surgery
- Uncontrolled hypertension during the operation (>180/110 mm Hg)
- Unrepairable rotator cuff tears
- Being unwilling to participate the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haseki Training and Research Hospital
Istanbul
About this study
Official title: Comparison of the Efficacy of Irrigation With Epinephrine or Tranexamic Acid on Visual Clarity During Arthroscopic Rotator Cuff Repair: A Randomized Double-Blind Study
The primary aim of this report is to determine whether there is a difference between Epinephrine and Tranexamic acid in providing visual clarity during arthroscopic rotator cuff tear repair.
- Conditions
- Rotator Cuff Tears
- Being tested
- tranexamic acid, Epinephrine
- Keywords
- shoulder arthroscopy, irrigation, epinephrine, image quality, tranexamic acid, cuff tear repair, visual clarity
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tranexamic acidDrug
Also called TRANSAMINE %5 5 ml 250 mg
Tranexamic acid is added to the irrigation fluid used in arthroscopic shoulder surgery.
EpinephrineDrug
Also called ADRENALIN 0,5 mg/1 m
Epinephrine is added to the irrigation fluid used in arthroscopic shoulder surgery.
| Study group | Role | What they receive |
|---|---|---|
| TXA group | Experimental | tranexamic acid added to irrigation solution Receives: Drug: tranexamic acid |
| EPN group | Experimental | epinephrine added to irrigation solution Receives: Drug: Epinephrine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale
Visual analog scale will be rated by surgeon. While 0 is the worst score with no clear vision, 10 was noted as the best score for visual clarity.
Measured: through study completion, an average of 2 year
Secondary outcomes (2)
total operating time
period in minutes from the time the arthroscope was inserted into the glenohumeral joint until the termination of the arthroscopic procedure
Measured: through study completion, an average of 2 year
average mean arterial pressure
mean arterial pressure per operation.
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start1 Feb 2017
- Primary completion30 Dec 2019
- Study completion30 Jan 2020
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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, erhan bayram, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628676
- Sponsor's protocol ID
- saglik bilimleri university
- Status last verified
- Nov 2020
- First submitted
- 29 Oct 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of Irrigation With Epinephrine or Tranexamic Acid on Visual Clarity During Arthroscopic Rotator Cuff Repair: A Randomized Double-Blind Study
- ClinicalTrials.gov ID
- NCT04628676
- Acronym / sponsor ID
- saglik bilimleri university
- Conditions
- Rotator Cuff Tears
- Keywords
- shoulder arthroscopy, irrigation, epinephrine, image quality, tranexamic acid, cuff tear repair, visual clarity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 13 Nov 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 primary aim of this report is to determine whether there is a difference between Epinephrine and Tranexamic acid in providing visual clarity during arthroscopic rotator cuff tear repair.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TXA group | Experimental | Drug: tranexamic acidtranexamic acid added to irrigation solution |
| EPN group | Experimental | Drug: Epinephrineepinephrine added to irrigation solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Age > 18 years
Key exclusion criteria (11 listed)
- • Age < 18 years
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 acidAlso: TRANSAMINE %5 5 ml 250 mgTranexamic acid is added to the irrigation fluid used in arthroscopic shoulder surgery. | Drug | TXA group |
| EpinephrineAlso: ADRENALIN 0,5 mg/1 mEpinephrine is added to the irrigation fluid used in arthroscopic shoulder surgery. | Drug | EPN group |
Primary outcome
Visual analog scale
Time frame: through study completion, an average of 2 year
Visual analog scale will be rated by surgeon. While 0 is the worst score with no clear vision, 10 was noted as the best score for visual clarity.
2 secondary outcomes
total operating time
Time frame: through study completion, an average of 2 year
average mean arterial pressure
Time frame: through study completion, an average of 2 year
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 13 Nov 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tranexamic acid and Epinephrine in people with Rotator Cuff Tears, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
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 4 inclusion and 11 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 13 Nov 2020. 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 Turkey (Türkiye). 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.
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?
Visual analog scale (time frame: through study completion, an average of 2 year). 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 13 Nov 2020.