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Antifibrinolytic Agent

Tranexamic Acid Injection (TXA) for Total Shoulder Replacement

Phase 4

Waitlist Available

Led By Uchenna Umeh, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up until 30 days after last day of study participation, an average of 6 weeks

Awards & highlights

Study Summary

This trial is testing whether two doses of Tranexamic Acid given to patients before and after surgery can reduce blood loss, surgical drain output, and hematoma formation compared to a control group who do not receive the drug.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up until 30 days after last day of study participation, an average of 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up until 30 days after last day of study participation, an average of 6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up until 30 days after last day of study participation, an average of 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Calculated Total Blood Loss

Total Surgical Drain Output

Secondary outcome measures

Average Operative Time

Number of Participants Who Needed a Post-op Blood Transfusion

Number of Participants With Presence of Hematoma

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Tranexamic Acid Injection (TXA)Experimental Treatment1 Intervention

Subjects scheduled to undergo TSA (anatomic and reverse) will receive TXA before surgical incision and 3 hours later.

Group II: No Tranexamic Acid Injection (TXA) givenActive Control1 Intervention

Subjects scheduled to undergo TSA (anatomic and reverse) will receive no TXA.

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Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,367 Previous Clinical Trials

839,704 Total Patients Enrolled

Uchenna Umeh, MDPrincipal InvestigatorNYU Langone Health

4 Previous Clinical Trials

337 Total Patients Enrolled

Arthur Hertling, MDPrincipal InvestigatorNYU Langone Health

3 Previous Clinical Trials

231 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots to join this clinical trial?

"According to clinicaltrials.gov, this trial is actively searching for participants. The original post date was October 6th 2020 and the most recent update occurred on July 7th 2022."

Answered by AI

What medical ailments does Tranexamic Acid Injection typically address?

"Tranexamic Acid Injection is often employed for the treatment of hyperfibrinolysis, as well as hemophilia and post-extraction bleeding."

Answered by AI

Has Tranexamic Acid Injection been subject to any prior medical experiments?

"As of now, 61 clinical trials related to Tranexamic Acid Injection are actively enrolling patients. Of those studies 26 have reached Phase 3 research status. The largest concentration is located in Kansas City but there exist 185 different sites conducting this trial worldwide."

Answered by AI

Is Tranexamic Acid Injection well tolerated by people?

"Tranexamic Acid Injection has already been approved, so it was assigned a safety rating of 3 on our scale."

Answered by AI

How many participants are taking part in this research initiative?

"Affirmative. Clinicaltrials.gov illustrates that this clinical trial is now recruiting participants, with a start date of October 6th 2020 and the most recent update being July 7th 2022. The study requires 82 patients to be recruited from one medical centre only."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

TXA in Anticoagulated Patients Study

2020. "TXA in Anticoagulated Patients Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04560010.