Total Shoulder Athroplasty
Conditions
Brief 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). 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.
Interventions
DRUGTranexamic Acid Injection (TXA)
Injection of 1 gram of IV TXA before surgical plus 1 gram of IV TXA three hours later
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
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.
Intervention 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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) * Heparin * Low molecular weight heparin * Factor Xa inhibitors * Apixaban (Eliquis) * Rivarixaban (Xatelto) * Edoxaban (Savaysa) * Dabigatran (Pradaxa) * Clopidogrel (Plavix) * Prasugrel (Effient) * Ticagrelor (Brilinta)
Exclusion criteria
* 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) * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Calculated Total Blood Loss | 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 | 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. |
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 | Up to 24 hours post-op | — |
| Average Operative Time | 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) | Up until 30 days after last day of study participation, an average of 6 weeks | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tranexamic Acid Injection (TXA) Subjects scheduled to undergo TSA (anatomic and reverse) will receive TXA before surgical incision and 3 hours later.
Tranexamic Acid Injection (TXA): Injection of 1 gram of IV TXA before surgical plus 1 gram of IV TXA three hours later | 8 |
| No Tranexamic Acid Injection (TXA) Given Subjects scheduled to undergo TSA (anatomic and reverse) will receive no TXA. | 9 |
| Total | 17 |
Baseline characteristics
| Characteristic | Tranexamic Acid Injection (TXA) | Total | No Tranexamic Acid Injection (TXA) Given |
|---|---|---|---|
| Age, Continuous | 71 years STANDARD_DEVIATION 7.71 | 72 years STANDARD_DEVIATION 7.511 | 72 years STANDARD_DEVIATION 6.944 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 15 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 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 | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 6 Participants | 13 Participants | 7 Participants |
| Region of Enrollment United States | 8 participants | 17 participants | 9 participants |
| Sex: Female, Male Female | 2 Participants | 9 Participants | 7 Participants |
| Sex: Female, Male Male | 6 Participants | 8 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 9 |
| other Total, other adverse events | 0 / 8 | 0 / 9 |
| serious Total, serious adverse events | 0 / 8 | 0 / 9 |
Outcome results
Primary
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: Baseline to 24 hours post op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tranexamic Acid Injection (TXA) | Calculated Total Blood Loss | 0.6632 Milliliters | Standard Deviation 0.2569 |
| No Tranexamic Acid Injection (TXA) Given | Calculated Total Blood Loss | 0.602 Milliliters | Standard Deviation 0.2228 |
Primary
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.
Time frame: Up to 24 hours post-op
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tranexamic Acid Injection (TXA) | Total Surgical Drain Output | 131.3 Milliliters | Standard Deviation 71.81 |
| No Tranexamic Acid Injection (TXA) Given | Total Surgical Drain Output | 146.7 Milliliters | Standard Deviation 75.7 |
Secondary
Average Operative Time
Time frame: During operation, up to 4 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tranexamic Acid Injection (TXA) | Average Operative Time | 88.25 minutes | Standard Deviation 24.85 |
| No Tranexamic Acid Injection (TXA) Given | Average Operative Time | 96 minutes | Standard Deviation 19.33 |
Secondary
Number of Participants Who Needed a Post-op Blood Transfusion
Time frame: Up to 24 hours post-op
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tranexamic Acid Injection (TXA) | Number of Participants Who Needed a Post-op Blood Transfusion | 0 Participants |
| No Tranexamic Acid Injection (TXA) Given | 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 Injection (TXA) | Number of Participants With Presence of Hematoma | 0 Participants |
| No Tranexamic Acid Injection (TXA) Given | Number of Participants With Presence of Hematoma | 1 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tranexamic Acid Injection (TXA) | Number of Patients Who Developed Adverse Events Such as Myocardial Infarction (MI), Pulmonary Embolus (PE), and/or Deep Vein Thrombosis (DVT) | 0 Participants |
| No Tranexamic Acid Injection (TXA) Given | Number of Patients Who Developed Adverse Events Such as Myocardial Infarction (MI), Pulmonary Embolus (PE), and/or Deep Vein Thrombosis (DVT) | 0 Participants |