drugset / Trial / NCT04560010

TXA in Anticoagulated Patients Study

NCT04560010 ↗

Phase 4 Terminated 17 enrolled NYU Langone Health
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2020-10-06
Primary completion
2023-03-11
Completion
2023-03-11

Outcome

Outcome not reported

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Tranexamic Acid Small molecule 1 g Intravenous

Indications

No indication recorded.