Arthropathy ShoulderPhase 4NCT04650698
TXA in Revision Total Shoulder Arthroplasty
A Phase 4 study testing Tranexamic acid (TXA) injection in people with Arthropathy Shoulder, run by NYU Langone Health at 1 site in United States.
Trial summary
This is a phase IV, randomized, single-blind, single-center study comparing calculated total blood loss, surgical drain output and hematoma formation in patients who receive 2 doses of Tranexamic Acid (TXA) versus control group undergoing revision total shoulder arthroplasty. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Arthropathy Shoulder
- What is being tested?
- Tranexamic acid (TXA) injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2021to 12 Mar 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years old
- Patients younger than 90 years old
- Patients undergoing scheduled revision total shoulder arthroplasty
- Patients who consent to be randomized
Who cannot join
- Patients younger than 18
- Patients older than 90 years old
- Patients who are pregnant or breast-feeding women
- Patients who are allergic to tranexamic acid
- Patients with proximal humerus fracture or fracture sequelae
- Patients who use estrogen containing medications (i.e. oral contraceptive pills)
Show all 21Show fewer
- Patients who have acquired disturbances of color vision
- Patients with a history of any of the following diagnosis: '
- Subarachnoid hemorrhage
- Active intravascular clotting
- Severe pulmonary disease (FEV <50% normal)
- Plasma creatinine > 115 μmol/L in males, > 100 μmol/L in females, or hepatic failure)
- (Renal impairment serum creatinine > 1.5 times the upper limit of normal NYU)
- Preoperative anemia [Hemoglobin (Hb) < 11g/dL in females, Hb < 12 g/dL in males]
- Patients who refuse blood products
- Patients undergoing hormone replacement therapy
- Patients with diagnosed or self-reported cognitive dysfunction;
- Patients who are unable to understand or follow instructions;
- Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;
- Patients with BMI over 50
- Any patient that the investigators feel cannot comply with all study related procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Langone Orthopedic Hospital
New York, New York, 10003
About this study
Official title: The Effect of Tranexamic Acid on Calculated Total Blood Loss in Patients Undergoing Revision Shoulder Arthroplasty
This is a phase IV, randomized, single-blind, single-center study comparing calculated total blood loss, surgical drain output and hematoma formation in patients who receive 2 doses of Tranexamic Acid (TXA) versus control group undergoing revision total shoulder arthroplasty. Patients will be randomized to either receive 2 doses of IV TXA, first dose prior to surgical incision and second dose given 3 hours later or to the control group, where no TXA will be administered.
Read the detailed description
The objectives of the study are to compare the effectiveness of IV TXA on reducing calculated total blood loss, surgical drain output and hematoma formation in patients undergoing revision total shoulder arthroplasty.
- Conditions
- Arthropathy Shoulder
- Being tested
- Tranexamic acid (TXA) injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acid (TXA) injectionDrug
Also called TXA
IV, Total Dosage: 2 grams (1 gram before surgical incision + 1 gram, 3 hours after first dose)
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid (TXA) Injection | Experimental | Participants scheduled for Revision Total Shoulder Arthroplasty (TSA) will receive two injections of TXA. Receives: Drug: Tranexamic acid (TXA) injection |
| Control - No Tranexamic acid (TXA) Injection | No intervention | Participants scheduled for Revision Total Shoulder Arthroplasty (TSA) won't receive any injections TXA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Calculated Total Blood Loss
The volume of perioperative blood loss will be determined on the basis of the blood volume and change in hemoglobin from preoperatively to 1 day postoperatively. The volume of total perioperative blood loss will be determined according to the following formula:
Total blood loss (ml) = 1000 x 〖Hb〗_loss/〖Hb〗_i
Measured: up to 24 hours post-op
Total Surgical Drain Output
The floor nurse will also document the amount of blood in the indwelling hemovac surgical drain placed in the operative shoulder joint up to 24 hours. The total surgical drain output will be calculated after 24 hours.
Measured: up to 24 hours post-op
Secondary outcomes (3)
Number of Participants With Presence of Hematoma
Surgeon will assess for presence of hematoma at the 2-week follow up visit.
Measured: 2 weeks post-op
Number of Participants Who Needed a Post-op Blood Transfusion
Measured: 2 weeks post-op
Average Operative Time
Measured: During operation, up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start7 Jan 2021
- Primary completion12 Mar 2023
- Study completion12 Mar 2023
Why it stopped: Enrollment rate was slower than anticipated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Arthropathy ShoulderStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arthur Hertling, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650698
- Sponsor's protocol ID
- 20-01617
- Status last verified
- Mar 2024
- First submitted
- 25 Nov 2020
- Last updated
- 12 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tranexamic Acid on Calculated Total Blood Loss in Patients Undergoing Revision Shoulder Arthroplasty
- ClinicalTrials.gov ID
- NCT04650698
- Acronym / sponsor ID
- 20-01617
- Conditions
- Arthropathy Shoulder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment rate was slower than anticipated.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 12 Mar 2023 (actual)
- Study completion
- 12 Mar 2023 (actual)
- First posted
- 3 Dec 2020 (actual)
- Results
- Posted 12 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase IV, randomized, single-blind, single-center study comparing calculated total blood loss, surgical drain output and hematoma formation in patients who receive 2 doses of Tranexamic Acid (TXA) versus control group undergoing revision total shoulder arthroplasty. Patients will be randomized to either receive 2 doses of IV TXA, first dose prior to surgical incision and second dose given 3 hours later or to the control group, where no TXA will be administered.
Detailed description
The objectives of the study are to compare the effectiveness of IV TXA on reducing calculated total blood loss, surgical drain output and hematoma formation in patients undergoing revision total shoulder arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid (TXA) Injection | Experimental | Drug: Tranexamic acid (TXA) injectionParticipants scheduled for Revision Total Shoulder Arthroplasty (TSA) will receive two injections of TXA. |
| Control - No Tranexamic acid (TXA) Injection | No intervention | –Participants scheduled for Revision Total Shoulder Arthroplasty (TSA) won't receive any injections TXA. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients older than 18 years old
- Patients younger than 90 years old
- Patients undergoing scheduled revision total shoulder arthroplasty
- Patients who consent to be randomized
Key exclusion criteria (21 listed)
- Patients younger than 18
- Patients older than 90 years old
- Patients who are pregnant or breast-feeding women
- Patients who are allergic to tranexamic acid
- Patients with proximal humerus fracture or fracture sequelae
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 (TXA) injectionAlso: TXAIV, Total Dosage: 2 grams (1 gram before surgical incision + 1 gram, 3 hours after first dose) | Drug | Tranexamic acid (TXA) Injection |
Primary outcome
Total Calculated Total Blood Loss
Time frame: up to 24 hours post-op
The volume of perioperative blood loss will be determined on the basis of the blood volume and change in hemoglobin from preoperatively to 1 day postoperatively. The volume of total perioperative blood loss will be determined according to the following formula: Total blood loss (ml) = 1000 x 〖Hb〗_loss/〖Hb〗_i
Total Surgical Drain Output
Time frame: up to 24 hours post-op
The floor nurse will also document the amount of blood in the indwelling hemovac surgical drain placed in the operative shoulder joint up to 24 hours. The total surgical drain output will be calculated after 24 hours.
3 secondary outcomes
Number of Participants With Presence of Hematoma
Time frame: 2 weeks post-op
Number of Participants Who Needed a Post-op Blood Transfusion
Time frame: 2 weeks post-op
Average Operative Time
Time frame: During operation, up to 4 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
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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.
Arthur Hertling, MD principal investigator
NYU Langone Health
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 Tranexamic acid (TXA) injection in people with Arthropathy Shoulder, run by NYU Langone Health 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 4 inclusion and 21 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: stopped early, as of the sponsor's last update on 12 Mar 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 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 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?
Yes. Results are posted in the registry (first posted 12 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Calculated Total Blood Loss (time frame: up to 24 hours post-op). 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 12 Mar 2024; AzTrials last refreshed its copy on 30 Oct 2026.