TXA in Anticoagulated Patients Study

The Effect of Tranexamic Acid in Anticoagulated Patients Undergoing Total Shoulder Athroplasty

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.

Study Overview

• Status: Terminated
• Conditions: Total Shoulder Athroplasty
• Intervention / Treatment: Drug: Tranexamic Acid Injection (TXA)

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Arthur Hertling, MD; Phone Number: 212-263-5072; Email: Arthur.hertling@nyulangone.org
• Study Contact Backup: Name: Avra Hammerschlag; Email: Avra.hammerschlag@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

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

Description

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.

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 Injection (TXA); Subjects scheduled to undergo TSA (anatomic and reverse) will receive TXA before surgical incision and 3 hours later.	Drug: Tranexamic Acid Injection (TXA); Injection of 1 gram of IV TXA before surgical plus 1 gram of IV TXA three hours later
No Intervention: No Tranexamic Acid Injection (TXA) given; Subjects scheduled to undergo TSA (anatomic and reverse) will receive no TXA.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 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
Average Operative Time		During operation, up to 4 hours
Number of Participants Who Needed a Post-op Blood Transfusion		Up to 24 hours post-op
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

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): October 6, 2020
• Primary Completion (Actual): March 11, 2023
• Study Completion (Actual): March 11, 2023

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: September 17, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 20-00803

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to the PI. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: 9 months and ending 36 months following article publication
• IPD Sharing Access Criteria: Requests may be directed to the PI.
• 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