TXA in Revision Total Shoulder Arthroplasty

The Effect of Tranexamic Acid on Calculated Total Blood Loss in Patients Undergoing Revision Shoulder Arthroplasty

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.

Study Overview

• Status: Terminated
• Conditions: Arthropathy Shoulder
• Intervention / Treatment: Drug: Tranexamic acid (TXA) injection

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Avra Hammerschlag; Phone Number: 212-598-6085; Email: Avra.Hammerschlag@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10003
      • NYU Langone Orthopedic Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tranexamic acid (TXA) Injection; Participants scheduled for Revision Total Shoulder Arthroplasty (TSA) will receive two injections of TXA.	Drug: Tranexamic acid (TXA) injection; IV, Total Dosage: 2 grams (1 gram before surgical incision + 1 gram, 3 hours after first dose); Other Names: TXA
No Intervention: Control - No Tranexamic acid (TXA) Injection; Participants scheduled for Revision Total Shoulder Arthroplasty (TSA) won't receive any injections TXA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	up to 24 hours post-op
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.	up to 24 hours post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Number of Participants Who Needed a Post-op Blood Transfusion		2 weeks post-op
Average Operative Time		During operation, up to 4 hours

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Arthur Hertling, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2021
• Primary Completion (Actual): March 12, 2023
• Study Completion (Actual): March 12, 2023

Study Registration Dates

• First Submitted: November 25, 2020
• First Submitted That Met QC Criteria: November 25, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 20-01617

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• IPD Sharing Access Criteria: The investigator who proposed to use the data upon reasonable request. Requests should be directed to Uchenna.Umeh@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes