TXA in Revision Total Shoulder Arthroplasty

NCT04650698 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 20-01617
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthropathy Shoulder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Number of Participants With Presence of Hematoma

  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

Study Arms (2)

Tranexamic acid (TXA) Injection

EXPERIMENTAL

Participants scheduled for Revision Total Shoulder Arthroplasty (TSA) will receive two injections of TXA.

Drug: Tranexamic acid (TXA) injection

Control - No Tranexamic acid (TXA) Injection

NO INTERVENTION

Participants scheduled for Revision Total Shoulder Arthroplasty (TSA) won't receive any injections TXA.

Interventions

Tranexamic acid (TXA) injection DRUG

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

Also known as: TXA

Tranexamic acid (TXA) Injection

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than 18 years old
• Patients younger than 90 years old
• Patients undergoing scheduled revision total shoulder arthroplasty
• Patients who consent to be randomized

You may not qualify if:

• Patients younger than 18
• Patients older than 90 years old
• Patients who are pregnant or breast-feeding women
• Patients who are allergic to tranexamic acid
• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Orthopedic Hospital

New York, New York, 10003, United States

Location

MeSH Terms

Interventions

Tranexamic Acid

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Arthur Hertling, MD
• Organization: NYU Langone

Arthur.Hertling@nyulangone.org

212-598-6085

Study Officials

• Arthur Hertling, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 3, 2020
• Study Start: January 7, 2021
• Primary Completion: March 12, 2023
• Study Completion: March 12, 2023
• Last Updated: March 12, 2024
• Results First Posted: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

US (1)