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Antifibrinolytic Agent

Tranexamic acid (TXA) Injection for Shoulder Arthropathy

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 to 24 hours post-op
Awards & highlights

Study Summary

This trial compares blood loss in shoulder surgery patients given two doses of Tranexamic Acid to a control group not given the medication.

Eligible Conditions
  • Shoulder Arthropathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 hours post-op
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 hours post-op for reporting.

Treatment Details

Study Objectives

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

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Tranexamic acid (TXA) InjectionExperimental Treatment1 Intervention
Participants scheduled for Revision Total Shoulder Arthroplasty (TSA) will receive two injections of TXA.
Group II: Control - No Tranexamic acid (TXA) InjectionActive Control1 Intervention
Participants scheduled for Revision Total Shoulder Arthroplasty (TSA) won't receive any injections TXA.

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,367 Previous Clinical Trials
839,702 Total Patients Enrolled
Uchenna Umeh, MDPrincipal InvestigatorNYU Langone Health
4 Previous Clinical Trials
335 Total Patients Enrolled
Arthur Hertling, MDPrincipal InvestigatorNYU Langone Health
3 Previous Clinical Trials
229 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 other research initiatives that have explored the effects of Tranexamic acid?

"Presently, there are 61 clinical trials examining Tranexamic acid with 26 at Phase 3. Primarily located in Kansas City, Kansas, these studies span 185 sites globally."

Answered by AI

Has Tranexamic acid been validated by the FDA?

"Due to the fact that tranexamic acid has already achieved Phase 4 approval, our team at Power rated this medication's safety a 3 on the 1-3 scale."

Answered by AI

How many subjects are being tracked in this clinical trial?

"Affirmative. According to the clinicaltrials.gov database, this research project is actively enrolling people. It was first advertised on July 1st 2021 and was last modified on August 23rd 2022. For now, 82 participants are needed from a single medical centre."

Answered by AI

What primary conditions does Tranexamic acid typically address?

"Tranexamic acid is commonly utilized to reduce fibrinolysis, as well as for therapeutic purposes in cases of hemophilia, bleeding episodes, and dental extractions."

Answered by AI

Are there any opportunities for volunteers to join this clinical experiment?

"According to clinicaltrials.gov, this medical experiment began recruiting on January 7th 2021 and has seen recent updates as of August 23rd 2022."

Answered by AI

Do I meet the necessary criteria to join this research study?

"The research team is searching for 82 people with joint issues, between 18 and 90 years of age. To qualify, candidates must provide consent to be randomized and possess the following criteria: being older than 18 years old and younger than 90 years old; plus undergoing a scheduled revision total shoulder arthroplasty."

Answered by AI

Do elderly individuals aged 75 and over qualify for this research endeavor?

"This clinical trial has set 18 years old as the minimum age for enrollment and 90 years old as the maximum."

Answered by AI
~4 spots leftby Apr 2025