Arthropathy Shoulder
Conditions
Brief 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. 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.
Interventions
IV, Total Dosage: 2 grams (1 gram before surgical incision + 1 gram, 3 hours after first dose)
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Neither the anesthesiologist or surgeon will be blinded to the patient's group assignment, as they will be the one performing the treatment. All other stakeholders (patient, other caregivers, and research staff collecting the data) will be blinded to the patient's group assignment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. Patients older than 18 years old 2. Patients younger than 90 years old 3. Patients undergoing scheduled revision total shoulder arthroplasty 4. Patients who consent to be randomized
Exclusion criteria
1. Patients younger than 18 2. Patients older than 90 years old 3. Patients who are pregnant or breast-feeding women 4. Patients who are allergic to tranexamic acid 5. Patients with proximal humerus fracture or fracture sequelae 6. Patients who use estrogen containing medications (i.e. oral contraceptive pills) 7. Patients who have acquired disturbances of color vision 8. 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 \[Hemoglobin (Hb) \< 11g/dL in females, Hb \< 12 g/dL in males\] 9. Patients who refuse blood products 10. Patients undergoing hormone replacement therapy 11. Patients with diagnosed or self-reported cognitive dysfunction; 12. Patients who are unable to understand or follow instructions; 13. Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease; 14. Patients with BMI over 50 15. Any patient that the investigators feel cannot comply with all study related procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Calculated Total Blood Loss | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Presence of Hematoma | 2 weeks post-op | Surgeon will assess for presence of hematoma at the 2-week follow up visit. |
| Number of Participants Who Needed a Post-op Blood Transfusion | 2 weeks post-op | — |
| Average Operative Time | During operation, up to 4 hours | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tranexamic Acid (TXA) Injection Participants scheduled for Revision Total Shoulder Arthroplasty (TSA) will receive two injections of TXA.
Tranexamic acid (TXA) injection: IV, Total Dosage: 2 grams (1 gram before surgical incision + 1 gram, 3 hours after first dose) | 10 |
| Control - No Tranexamic Acid (TXA) Injection Participants scheduled for Revision Total Shoulder Arthroplasty (TSA) won't receive any injections TXA. | 5 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 2 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Tranexamic Acid (TXA) Injection | Total | Control - No Tranexamic Acid (TXA) Injection |
|---|---|---|---|
| Age, Continuous | 67.5 years STANDARD_DEVIATION 6.685 | 63 years STANDARD_DEVIATION 8.21 | 62 years STANDARD_DEVIATION 8.98 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 13 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 10 Participants | 12 Participants | 2 Participants |
| Region of Enrollment United States | 10 participants | 15 participants | 5 participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 1 Participants |
| Sex: Female, Male Male | 8 Participants | 12 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 5 |
| other Total, other adverse events | 0 / 10 | 0 / 5 |
| serious Total, serious adverse events | 0 / 10 | 0 / 5 |
Outcome results
Primary
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
Time frame: up to 24 hours post-op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tranexamic Acid (TXA) Injection | Total Calculated Total Blood Loss | 0.5952 Milliliters | Standard Deviation 0.3312 |
| Control - No Tranexamic Acid (TXA) Injection | Total Calculated Total Blood Loss | 0.8306 Milliliters | Standard Deviation 0.3641 |
Primary
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.
Time frame: up to 24 hours post-op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tranexamic Acid (TXA) Injection | Total Surgical Drain Output | 101.5 Milliliters | Standard Deviation 88.43 |
| Control - No Tranexamic Acid (TXA) Injection | Total Surgical Drain Output | 153 Milliliters | Standard Deviation 129 |
Secondary
Average Operative Time
Time frame: During operation, up to 4 hours
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Tranexamic Acid (TXA) Injection | Average Operative Time | 104.6 minutes | Standard Deviation 26.12 |
| Control - No Tranexamic Acid (TXA) Injection | Average Operative Time | 130.4 minutes | Standard Deviation 37.58 |
Secondary
Number of Participants Who Needed a Post-op Blood Transfusion
Time frame: 2 weeks post-op
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tranexamic Acid (TXA) Injection | Number of Participants Who Needed a Post-op Blood Transfusion | 0 Participants |
| Control - No Tranexamic Acid (TXA) Injection | Number of Participants Who Needed a Post-op Blood Transfusion | 0 Participants |
Secondary
Number of Participants With Presence of Hematoma
Surgeon will assess for presence of hematoma at the 2-week follow up visit.
Time frame: 2 weeks post-op
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tranexamic Acid (TXA) Injection | Number of Participants With Presence of Hematoma | 1 Participants |
| Control - No Tranexamic Acid (TXA) Injection | Number of Participants With Presence of Hematoma | 0 Participants |