NCT04650698

TXA in Revision Total Shoulder Arthroplasty

The Effect of Tranexamic Acid on Calculated Total Blood Loss in Patients Undergoing Revision Shoulder Arthroplasty

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The objectives of the study are to compare the effectiveness of IV TXA on reducing calculated total blood loss, surgical drain output and hematoma formation in patients undergoing revision total shoulder arthroplasty.

Conditions

• Arthropathy Shoulder

Interventions

Type	Name	Description
DRUG	Tranexamic acid (TXA) injection	IV, Total Dosage: 2 grams (1 gram before surgical incision + 1 gram, 3 hours after first dose)

Timeline

• Start date: 2021-01-07
• Primary completion: 2023-03-12
• Completion: 2023-03-12
• First posted: 2020-12-03
• Last updated: 2024-03-12
• Results posted: 2024-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study