Total Shoulder AthroplastyPhase 4NCT04560010
TXA in Anticoagulated Patients Study
A Phase 4 study testing Tranexamic Acid Injection (TXA) in people with Total Shoulder Athroplasty, run by NYU Langone Health at 1 site in United States.
Trial summary
This is a randomized, single-blind, single-center study comparing calculated total blood loss, surgical drain output and hematoma formation in anticoagulated patients who receive 2 doses of Tranexamic Acid (TXA) versus control group undergoing anatomical and reverse total shoulder arthroplasty (TSA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Shoulder Athroplasty
- What is being tested?
- Tranexamic Acid Injection (TXA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Oct 2020to 11 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients older than 18 years old
- Patients undergoing scheduled primary anatomic total shoulder arthroplasty
- Patients undergoing scheduled primary reverse total shoulder arthroplasty
- Patients who consent to be randomized
- Preoperative use of anticoagulant or antiplatelet therapy within 10 days prior to surgery:
- Coumadin (Warfarin)
Show all 16Show fewer
- Heparin
- Low molecular weight heparin
- Factor Xa inhibitors
- Apixaban (Eliquis)
- Rivarixaban (Xatelto)
- Edoxaban (Savaysa)
- Dabigatran (Pradaxa)
- Clopidogrel (Plavix)
- Prasugrel (Effient)
- Ticagrelor (Brilinta)
Who cannot join
- Patients younger than 18
- Patients who are pregnant* or breast-feeding women
- Patients who are allergic to tranexamic acid
- Patients scheduled for revision total shoulder arthroplasty
- 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.
About this study
Official title: The Effect of Tranexamic Acid in Anticoagulated Patients Undergoing Total Shoulder Athroplasty
This is a randomized, single-blind, single-center study comparing calculated total blood loss, surgical drain output and hematoma formation in anticoagulated patients who receive 2 doses of Tranexamic Acid (TXA) versus control group undergoing anatomical and reverse total shoulder arthroplasty (TSA). 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.
- Conditions
- Total Shoulder Athroplasty
- Being tested
- Tranexamic Acid Injection (TXA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid Injection (TXA)Drug
Injection of 1 gram of IV TXA before surgical plus 1 gram of IV TXA three hours later
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic Acid Injection (TXA) | Experimental | Subjects scheduled to undergo TSA (anatomic and reverse) will receive TXA before surgical incision and 3 hours later. Receives: Drug: Tranexamic Acid Injection (TXA) |
| No Tranexamic Acid Injection (TXA) given | No intervention | Subjects scheduled to undergo TSA (anatomic and reverse) will receive no TXA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Baseline to 24 hours post op
Total Surgical Drain Output
Surgical drain output will be recorded by floor nurse every 8 hours in EPIC. Data will be recorded up to 24 hours post-op if needed.
Measured: Up to 24 hours post-op
Secondary outcomes (4)
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: Up to 24 hours post-op
Average Operative Time
Measured: During operation, up to 4 hours
Number of Patients Who Developed Adverse Events Such as Myocardial Infarction (MI), Pulmonary Embolus (PE), and/or Deep Vein Thrombosis (DVT)
Measured: Up until 30 days after last day of study participation, an average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start6 Oct 2020
- Primary completion11 Mar 2023
- Study completion11 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 Total Shoulder AthroplastyStudies 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
- Model description
- Subjects scheduled to undergo TSA (anatomic and reverse) will be randomized to receive one of two treatment options. This study will utilize a simple randomization approach to generate two-equal groups. All subjects have an equal chance (1:2) of getting randomized into one of the twp treatments groups: (1) Two doses of IV TXA, one before incision and the second 3 hours later. (2) control group - no TXA given. Randomization of each subject will be done on day of surgery. The randomization schedule will be generated using a computer software program such as randomization.com
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 17 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
- NCT04560010
- Sponsor's protocol ID
- 20-00803
- Status last verified
- Feb 2024
- First submitted
- 17 Sep 2020
- Last updated
- 26 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to the PI. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tranexamic Acid in Anticoagulated Patients Undergoing Total Shoulder Athroplasty
- ClinicalTrials.gov ID
- NCT04560010
- Acronym / sponsor ID
- 20-00803
- Conditions
- Total Shoulder Athroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment rate was slower than anticipated
- Enrolment
- 17 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 6 Oct 2020 (actual)
- Primary completion
- 11 Mar 2023 (actual)
- Study completion
- 11 Mar 2023 (actual)
- First posted
- 23 Sep 2020 (actual)
- Results
- Posted 26 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 randomized, single-blind, single-center study comparing calculated total blood loss, surgical drain output and hematoma formation in anticoagulated patients who receive 2 doses of Tranexamic Acid (TXA) versus control group undergoing anatomical and reverse total shoulder arthroplasty (TSA). 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects scheduled to undergo TSA (anatomic and reverse) will be randomized to receive one of two treatment options. This study will utilize a simple randomization approach to generate two-equal groups. All subjects have an equal chance (1:2) of getting randomized into one of the twp treatments groups: (1) Two doses of IV TXA, one before incision and the second 3 hours later. (2) control group - no TXA given. Randomization of each subject will be done on day of surgery. The randomization schedule will be generated using a computer software program such as randomization.com
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid Injection (TXA) | Experimental | Drug: Tranexamic Acid Injection (TXA)Subjects scheduled to undergo TSA (anatomic and reverse) will receive TXA before surgical incision and 3 hours later. |
| No Tranexamic Acid Injection (TXA) given | No intervention | –Subjects scheduled to undergo TSA (anatomic and reverse) will receive no TXA. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients older than 18 years old
- Patients undergoing scheduled primary anatomic total shoulder arthroplasty
- Patients undergoing scheduled primary reverse total shoulder arthroplasty
- Patients who consent to be randomized
- Preoperative use of anticoagulant or antiplatelet therapy within 10 days prior to surgery:
Key exclusion criteria (21 listed)
- Patients younger than 18
- Patients who are pregnant* or breast-feeding women
- Patients who are allergic to tranexamic acid
- Patients scheduled for revision total shoulder arthroplasty
- 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 Injection (TXA)Injection of 1 gram of IV TXA before surgical plus 1 gram of IV TXA three hours later | Drug | Tranexamic Acid Injection (TXA) |
Primary outcome
Calculated Total Blood Loss
Time frame: Baseline 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
Surgical drain output will be recorded by floor nurse every 8 hours in EPIC. Data will be recorded up to 24 hours post-op if needed.
4 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: Up to 24 hours post-op
Average Operative Time
Time frame: During operation, up to 4 hours
Number of Patients Who Developed Adverse Events Such as Myocardial Infarction (MI), Pulmonary Embolus (PE), and/or Deep Vein Thrombosis (DVT)
Time frame: Up until 30 days after last day of study participation, an average of 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to the PI. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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 Injection (TXA) in people with Total Shoulder Athroplasty, 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 16 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 26 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 26 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?
Calculated Total Blood Loss (time frame: Baseline 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 26 Mar 2024.