drugset / Trial / NCT04650698

TXA in Revision Total Shoulder Arthroplasty

NCT04650698 ↗

Phase 4 Terminated 19 enrolled NYU Langone Health
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2021-01-07
Primary completion
2023-03-12
Completion
2023-03-12

Outcome

Outcome not reported

Stopped (Enrollment): “Enrollment rate was slower than anticipated.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Tranexamic Acid Small molecule 1 g Intravenous

Indications