Tranexamic acid for Shoulder Arthropathy

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
NYU Langone Orthopedic Hospital, New York, NYShoulder ArthropathyTranexamic acid - Drug
Eligibility
18 - 90
All Sexes
What conditions do you have?
Select

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

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: up to 24 hours post-op

2 weeks post-op
Number of participants who needed a post-op blood transfusion
Number of participants with presence of hematoma
Hour 4
Operative time
Hour 24
Total calculated total blood loss
Total surgical drain output

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Tranexamic Group
22%Readmissions
14%Postoperative infections
10%Re-operations
4%Thromboembolic events
This histogram enumerates side effects from a completed 2012 Phase 4 trial (NCT00740116) in the Tranexamic Group ARM group. Side effects include: Readmissions with 22%, Postoperative infections with 14%, Re-operations with 10%, Thromboembolic events with 4%.

Trial Design

2 Treatment Groups

Control
1 of 2
Tranexamic acid (TXA)
1 of 2

Active Control

Experimental Treatment

82 Total Participants · 2 Treatment Groups

Primary Treatment: Tranexamic acid · No Placebo Group · Phase 4

Tranexamic acid (TXA)
Drug
Experimental Group · 1 Intervention: Tranexamic acid · Intervention Types: Drug
ControlNoIntervention Group · 1 Intervention: Control · Intervention Types:
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tranexamic acid
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 hours post-op

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,276 Previous Clinical Trials
758,129 Total Patients Enrolled
Uchenna Umeh, MDPrincipal InvestigatorNYU Langone Health
3 Previous Clinical Trials
370 Total Patients Enrolled
Arthur Hertling, MDPrincipal InvestigatorNYU Langone Health
3 Previous Clinical Trials
334 Total Patients Enrolled

Eligibility Criteria

Age 18 - 90 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You agree to be assigned randomly to a treatment group.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.