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Anti-fibrinolytic agent

Nebulized Tranexamic Acid for Hemorrhage (TEAPOT Trial)

Phase < 1
Waitlist Available
Led By Andrew D Meyer, MD, MS
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Received a tonsillectomy
2. Presents to the ED with secondary\* post-tonsillectomy hemorrhage
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 18 months (or duration of study)
Awards & highlights

Summary

After a child has their tonsils removed, sometimes they might bleed which can be a problem. There is a special mist medicine called nebulized tranexamic acid (TXA) that might help stop the bleeding without having to touch the sore spot. If this mist works well, it could help kids get better by making sure they don't have to go back for more surgery or need blood from someone else. Not having another surgery is good because it means kids won't have to sleep under medicine again, which can sometimes be risky for their brains and breathing, and they won't feel as scared or hurt.

Who is the study for?
This trial is for children who have had their tonsils removed and are experiencing bleeding afterwards. It's important that they haven't had any reactions to tranexamic acid before, and they aren't currently taking medication that affects blood clotting.
What is being tested?
The study is testing a mist medicine called nebulized tranexamic acid (TXA) against normal saline to see if TXA can stop post-operative bleeding in kids without additional surgery or the need for blood transfusions.
What are the potential side effects?
Tranexamic acid may cause side effects like headaches, muscle cramps, or an upset stomach. In rare cases, it could cause more serious problems like blood clots or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 18 months (or duration of study)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 18 months (or duration of study) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Indirect local concentration of nebulized TXA
Number of nebulizations per patient
Number of patients enrolled per month
+1 more
Secondary study objectives
Estimated blood loss
Number of blood transfusions required
Number of recurrences of PTH
+1 more
Other study objectives
State-Trait Anxiety Inventory (STAI) for Adults
State-Trait Anxiety Inventory for Children (STAIC)
Wong-Baker FACES Pain Rating Scale

Side effects data

From 2017 Phase 4 trial • 246 Patients • NCT02030821
7%
Deep Infection
4%
Superficial Cellulitis
2%
Hematoma/Seroma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tranexamic Acid (TXA) - Total Hip Arthroplasty
Epsilon-aminocaproic Acid (Amicar) - Total Hip Arthroplasty
Epsilon-aminocaproic Acid (Amicar) - Total Knee Arthroplasty
Tranexamic Acid (TXA) - Total Knee Arthroplasty

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Nebulized Tranexamic AcidExperimental Treatment1 Intervention
Subjects will be adminstered nebulized TXA post-tonsillectomy if they return to the emergency room with hemorrhage after surgery
Group II: Nebulized SalinePlacebo Group1 Intervention
Subjects will be adminstered nebulized saline post-tonsillectomy if they return to the emergency room with hemorrhage after surgery
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tranexamic Acid Injectable Product
2020
Completed Phase 4
~430

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor
458 Previous Clinical Trials
91,601 Total Patients Enrolled
5 Trials studying Hemorrhage
7,546 Patients Enrolled for Hemorrhage
Andrew D Meyer, MD, MSPrincipal InvestigatorThe University of Texas Health Science Center at San Antonio
~8 spots leftby Sep 2027
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