TXA in Revision Total Shoulder Arthroplasty

Overview

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.

Full Title of Study: “The Effect of Tranexamic Acid on Calculated Total Blood Loss in Patients Undergoing Revision Shoulder Arthroplasty”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Double (Participant, Care Provider)
• Study Primary Completion Date: March 12, 2023

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

• Drug: Tranexamic acid
  • IV, Total Dosage: 2 grams (1 gram before surgical incision + 1 gram, 3 hours after first dose)

Arms, Groups and Cohorts

• Experimental: Tranexamic acid (TXA)
  • IV TXA
• No Intervention: Control
  • No TXA

Clinical Trial Outcome Measures

Primary Measures

• 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. The drain output will be documented every 8 hours. We will record the drain output for the first 16 hours after surgery – essentially 2 output shifts. If patients are in the hospital longer, we will record the third 24 hour drain output.

Secondary Measures

• 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
• Operative time
  • Time Frame: During operation, up to 4 hours

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • NYU Langone Health
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Arthur Hertling, MD, Principal Investigator, NYU Langone Health