TXA in Anticoagulated Patients Study

Phase 4

Terminated

• Conditions: Total Shoulder Athroplasty
• Interventions: Drug: Tranexamic Acid Injection (TXA)

• Registration Number: NCT04560010
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-17
• Study First Submitted QC: 2020-09-17
• Study First Posted: 2020-09-23
• Study Start: 2020-10-06
• Primary Completion: 2023-03-11
• Study Completion: 2023-03-11
• Status Verified: 2024-02
• Results First Submitted: 2024-02-01
• Results First Submitted QC: 2024-02-27
• Last Update Submitted: 2024-02-27
• Results First Posted: 2024-03-26
• Last Update Posted: 2024-03-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic Acid Injection (TXA)	Tranexamic Acid Injection (TXA)	Subjects scheduled to undergo TSA (anatomic and reverse) will receive TXA before surgical incision and 3 hours later.

Primary Outcome Measures

Name	Time	Method
Calculated Total Blood Loss	Baseline to 24 hours post op	"The volume of perioperative blood loss will be determined on the basis of the blood volume and change in hemoglobin from preoperatively to 1 day postoperatively. The volume of total perioperative blood loss will be determined according to the following formula: Total blood loss (ml) = 1000 x 〖Hb〗_loss/〖Hb〗_i"
Total Surgical Drain Output	Up to 24 hours post-op	Surgical drain output will be recorded by floor nurse every 8 hours in EPIC. Data will be recorded up to 24 hours post-op if needed.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Needed a Post-op Blood Transfusion	Up to 24 hours post-op
Average Operative Time	During operation, up to 4 hours
Number of Participants With Presence of Hematoma	2 weeks post-op	Surgeon will assess for presence of hematoma at the 2-week follow up visit.
Number of Patients Who Developed Adverse Events Such as Myocardial Infarction (MI), Pulmonary Embolus (PE), and/or Deep Vein Thrombosis (DVT)	Up until 30 days after last day of study participation, an average of 6 weeks

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States