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TXA in Anticoagulated Patients Study

NCT04560010 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-03-26

Study results available
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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

Interventions

DRUG

Tranexamic Acid Injection (TXA)

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

Sponsors & Collaborators

Principal Investigators

  • Arthur Hertling, MD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-06
Primary Completion
2023-03-11
Completion
2023-03-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04560010 on ClinicalTrials.gov