Total Shoulder Athroplasty Clinical Trial
Official title:
The Effect of Tranexamic Acid in Anticoagulated Patients Undergoing Total Shoulder Athroplasty
| Verified date | February 2024 |
| Source | NYU Langone Health |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 17 |
| Est. completion date | March 11, 2023 |
| Est. primary completion date | March 11, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | NYU Langone Health | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| NYU Langone Health |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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" |
Baseline to 24 hours post op | |
| 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. | Up to 24 hours post-op | |
| Secondary | Number of Participants With Presence of Hematoma | Surgeon will assess for presence of hematoma at the 2-week follow up visit. | 2 weeks post-op | |
| Secondary | Number of Participants Who Needed a Post-op Blood Transfusion | Up to 24 hours post-op | ||
| Secondary | Average Operative Time | During operation, up to 4 hours | ||
| Secondary | 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 |