TXA in Revision Total Shoulder Arthroplasty

• ClinicalTrials.gov Identifier: NCT04650698
• Recruitment Status: Recruiting
• First Posted: December 3, 2020
• Last Update Posted: October 14, 2021
• Sponsor: NYU Langone Health
• Information provided by (Responsible Party): NYU Langone Health

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Arthropathy Shoulder	Drug: Tranexamic acid	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• 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.
• Primary Purpose: Treatment
• Official Title: The Effect of Tranexamic Acid on Calculated Total Blood Loss in Patients Undergoing Revision Shoulder Arthroplasty
• Actual Study Start Date: November 24, 2020
• Estimated Primary Completion Date: November 24, 2023
• Estimated Study Completion Date: November 24, 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Tranexamic acid (TXA); IV TXA	Drug: Tranexamic acid; IV, Total Dosage: 2 grams (1 gram before surgical incision + 1 gram, 3 hours after first dose); Other Name: TXA
No Intervention: Control; No TXA

Outcome Measures

Primary Outcome Measures :

1. 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

2. 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 Outcome Measures :

1. Number of participants with presence of hematoma [ Time Frame: 2 weeks post-op ]
2. Number of participants who needed a post-op blood transfusion [ Time Frame: 2 weeks post-op ]
3. Operative time [ Time Frame: During operation, up to 4 hours ]

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Contacts

Contact: Uchenna Umeh, MD; 212-598-6085; Uchenna.Umeh@nyulangone.org

Contact: Juan Caruci; 212-598-6085; Juan.Caruci@nyulangone.org

Locations

United States, New York

NYU Langone Orthopedic Hospital; Recruiting

New York, New York, United States, 10003

Contact: Uchenna Umeh, MD Uchenna.Umeh@nyulangone.org

Contact: Juan Caruci Juan.Caruci@nyulangone.org

Principal Investigator: Uchenna Umeh, MD

Sub-Investigator: Arthur Hertling, MD

Sub-Investigator: Young Kwon, MD, PhD

Sub-Investigator: Mandeep Virk, MD

Sub-Investigator: Joseph Zuckerman, MD

Sub-Investigator: Jesse Ng, MD

Sub-Investigator: Germaine Cuff, PhD

Sponsors and Collaborators

NYU Langone Health

Investigators

• Principal Investigator: Uchenna Umeh, MD; NYU Langone Health

More Information

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT04650698
• Other Study ID Numbers: 20-01617
• First Posted: December 3, 2020
• Last Update Posted: October 14, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP)
• 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.
• 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.

• 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

Additional relevant MeSH terms:

Joint Diseases; Musculoskeletal Diseases; Tranexamic Acid; Antifibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Hemostatics; Coagulants