TXA in Anticoagulated Patients Study

NCT ID: NCT04560010

Last Updated: 2024-03-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-06
• Study Completion Date: 2023-03-11

Brief Summary

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.

Conditions

Total Shoulder Athroplasty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Tranexamic Acid Injection (TXA)

Subjects scheduled to undergo TSA (anatomic and reverse) will receive TXA before surgical incision and 3 hours later.

Group Type: EXPERIMENTAL

Tranexamic Acid Injection (TXA)

Intervention Type: DRUG

Injection of 1 gram of IV TXA before surgical plus 1 gram of IV TXA three hours later

No Tranexamic Acid Injection (TXA) given

Subjects scheduled to undergo TSA (anatomic and reverse) will receive no TXA.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Tranexamic Acid Injection (TXA)

Injection of 1 gram of IV TXA before surgical plus 1 gram of IV TXA three hours later

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arthur Hertling, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20-00803

Identifier Type: -

Identifier Source: org_study_id