Shoulder ArthroscopyPhase 3NCT04610164
The Effect of Tranexamic Acid (TXA) on Visualization During Shoulder Arthroscopy
A Phase 3 study testing Tranexamic acid in people with Shoulder Arthroscopy and Operative Bleeding, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
Tranexamic acid has seen an increase in use over the past decade in hip and knee arthroplasty as well as spine surgery with more recent use seen in total shoulder arthroplasty (TSA). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Arthroscopy, Operative Bleeding, Postoperative Pain
- What is being tested?
- Tranexamic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2019to 31 Dec 2020
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- participants aged 18-80
- participants with an ASA (American Society of Anesthesiologists) score 1-3
- participants with a surgical indication of full thickness small to massive rotator cuff tear.
Who cannot join
- pregnant females,
- participants with a known allergy to tranexamic acid,
- participants with active thromboembolic disease,
- participants with seizure disorder,
- participants with prior cerebrovascular accident (CVA),
- history of cardiac stents or past history of thromboembolic disease,
- presence of full-thickness subscapularis tear (>50%),
- participants with irreparable rotator cuff tears.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: The Effect of Tranexamic Acid on Visualization During Shoulder Arthroscopy
Tranexamic acid has seen an increase in use over the past decade in hip and knee arthroplasty as well as spine surgery with more recent use seen in total shoulder arthroplasty (TSA). The mechanism of action of TXA is as a lysine analogue that competitively inhibits the conversion of plasminogen to plasmin thus resulting in its antifibrinolytic activity. Investigators have showed that compared with placebo TXA had a statistically significant effect on blood and postoperative hemoglobin levels in TSA. To date there are no studies investigating the effect of TXA in arthroscopy of any kind or studies examining the ability of TXA to aid in surgeon visualization in arthroscopic procedures. The investigators of this study will use change in pump pressure as a surrogate objective measure for surgeon visualization. The hypothesis is that participants who receive TXA will have a lower change in pump pressure compared to participants who do not receive TXA.
- Conditions
- Shoulder Arthroscopy, Operative Bleeding, Postoperative Pain
- Being tested
- Tranexamic acid
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Prior to surgery, the patient will receive 1 gram of IV TXA
| Study group | Role | What they receive |
|---|---|---|
| Group 1: TXA group | Experimental | Patient will receive 1 gram intravenous TXA prior to surgery Receives: Drug: Tranexamic acid |
| Group 2: Control Group | No intervention | Patient will not receive TXA prior to surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in operative factors
change in pump pressure (ΔP) during shoulder arthroscopy with a change in pump pressure of 15 mmHg set as the marker of surgeon visualization of the shoulder joint during surgery.
Measured: 2 hours
Postoperative pain
Investigators will be measuring whether there is a decrease in participants pain after surgery as assessed by visual analog score 7 days after surgery
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start19 Jun 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder ArthroscopyStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610164
- Sponsor's protocol ID
- SNAM18d.610
- Status last verified
- Oct 2020
- First submitted
- 21 Oct 2020
- Last updated
- 30 Oct 2020
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tranexamic Acid on Visualization During Shoulder Arthroscopy
- ClinicalTrials.gov ID
- NCT04610164
- Acronym / sponsor ID
- SNAM18d.610
- Conditions
- Shoulder Arthroscopy, Operative Bleeding, Postoperative Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 30 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.
Tranexamic acid has seen an increase in use over the past decade in hip and knee arthroplasty as well as spine surgery with more recent use seen in total shoulder arthroplasty (TSA). The mechanism of action of TXA is as a lysine analogue that competitively inhibits the conversion of plasminogen to plasmin thus resulting in its antifibrinolytic activity. Investigators have showed that compared with placebo TXA had a statistically significant effect on blood and postoperative hemoglobin levels in TSA. To date there are no studies investigating the effect of TXA in arthroscopy of any kind or studies examining the ability of TXA to aid in surgeon visualization in arthroscopic procedures. The investigators of this study will use change in pump pressure as a surrogate objective measure for surgeon visualization. The hypothesis is that participants who receive TXA will have a lower change in pump pressure compared to participants who do not receive TXA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: TXA group | Experimental | Drug: Tranexamic acidPatient will receive 1 gram intravenous TXA prior to surgery |
| Group 2: Control Group | No intervention | –Patient will not receive TXA prior to surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- participants aged 18-80
- participants with an ASA (American Society of Anesthesiologists) score 1-3
- participants with a surgical indication of full thickness small to massive rotator cuff tear.
Key exclusion criteria (8 listed)
- pregnant females,
- participants with a known allergy to tranexamic acid,
- participants with active thromboembolic disease,
- participants with seizure disorder,
- participants with prior cerebrovascular accident (CVA),
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 acidPrior to surgery, the patient will receive 1 gram of IV TXA | Drug | Group 1: TXA group |
Primary outcome
Changes in operative factors
Time frame: 2 hours
change in pump pressure (ΔP) during shoulder arthroscopy with a change in pump pressure of 15 mmHg set as the marker of surgeon visualization of the shoulder joint during surgery.
Postoperative pain
Time frame: 7 days
Investigators will be measuring whether there is a decrease in participants pain after surgery as assessed by visual analog score 7 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 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 Phase 3 study testing Tranexamic acid in people with Shoulder Arthroscopy and Operative Bleeding, run by Rothman Institute Orthopaedics at 1 site in United States.
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 3 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: status not confirmed, as of the sponsor's last update on 30 Oct 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 United States. 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?
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?
Changes in operative factors (time frame: 2 hours). The study lists 2 primary outcomes in all. 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 30 Oct 2020; AzTrials last refreshed its copy on 2 Nov 2026.