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Antifibrinolytic agent

Tranexamic Acid for Broken Arm (TXA Trial)

Phase 2
Recruiting
Led By Peter Tang, MD
Research Sponsored by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Isolated proximal humerus or humeral shaft fracture undergoing open reduction internal fixation
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of one year.
Awards & highlights

TXA Trial Summary

This trial will test if TXA can reduce blood loss, transfusions, wound complications, op. time & hospital stays.

Who is the study for?
This trial is for adults aged 18-100 with a broken upper arm bone needing surgery, who can read and understand English. It's not for those allergic to TXA, with color vision issues, history of blood clots or stroke, pregnant/breastfeeding women, recent heart attack patients or stent recipients, people refusing blood products, with certain brain hemorrhages or widespread clotting disorders.Check my eligibility
What is being tested?
Researchers are testing if Tranexamic Acid (TXA), which helps blood clot, can reduce bleeding during and after arm bone surgery. They want to see if it lowers the need for transfusions and cuts down on complications like infections. They're also checking if it shortens surgery time and hospital stays.See study design
What are the potential side effects?
Potential side effects of TXA may include an increased risk of blood clots leading to conditions such as deep vein thrombosis or stroke. Patients might also experience less common side effects related to its impact on the body's clotting system.

TXA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am having surgery for a broken upper arm bone.

TXA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Blood loss
Secondary outcome measures
Complications (DVT, PE, stroke)
Duration of follow-up
Operative Time

TXA Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment ArmExperimental Treatment1 Intervention
Patients randomized to treatment arm of study will have TXA administered 10 minutes prior to surgery
Group II: Control GroupPlacebo Group1 Intervention
The control group will have saline administered 10 minutes prior to surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tranexamic acid (TXA)
2013
Completed Phase 4
~280

Find a Location

Who is running the clinical trial?

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Lead Sponsor
47 Previous Clinical Trials
12,949 Total Patients Enrolled
Peter Tang, MDPrincipal InvestigatorAllegheny Health Network Allegheny General Hospital

Media Library

Tranexamic acid (TXA) (Antifibrinolytic agent) Clinical Trial Eligibility Overview. Trial Name: NCT05802238 — Phase 2
Broken Humerus Research Study Groups: Treatment Arm, Control Group
Broken Humerus Clinical Trial 2023: Tranexamic acid (TXA) Highlights & Side Effects. Trial Name: NCT05802238 — Phase 2
Tranexamic acid (TXA) (Antifibrinolytic agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05802238 — Phase 2

Frequently Asked Questions

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

Does this experiment accept participants aged fifty and above?

"Eligible candidates for this trial must be between the age of 18 and 100 years old."

Answered by AI

What potential health hazards have been associated with Treatment Arm?

"Our team at Power gave Treatment Arm a score of 2 as it is only in its second phase, meaning that while there has been some evidence to support safety, no data regarding efficacy has yet been collected."

Answered by AI

Are there any opportunities for participants to join this experiment?

"Clinicaltrials.gov reveals that recruitment for this study was closed on April 5th 2023, following an initial post date of April 1st 2023. Nonetheless, 37 other clinical trials are currently open to patient enrollment at present."

Answered by AI

Do I meet the qualifications for participation in this research project?

"The protocol for this medical trial permits up to 130 patients with a broken humerus between ages 18 and 100. For inclusion in the research, people must be male or female, present an isolated proximal humerus fracture or humeral shaft fracture that necessitates open reduction internal fixation surgery."

Answered by AI
~87 spots leftby Jun 2028