Tranexamic Acid for Tonsillar Bleeding

(TEAPOT Trial)

Not yet recruiting at 2 trial locations
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SP
Overseen ByStephanie Perez, MHA
Age: < 18
Sex: Any
Trial Phase: Phase < 1
Sponsor: The University of Texas Health Science Center at San Antonio

What You Need to Know Before You Apply

What is the purpose of this trial?

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 on the Research Team?

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Andrew D Meyer, MD, MS

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

Inclusion Criteria

I have bleeding after a tonsillectomy and came to the emergency room.
I am between 2 and 17 years old and had bleeding more than 24 hours after tonsil removal.
I have had my tonsils removed.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive three consecutive doses of nebulized tranexamic acid (TXA) over approximately an hour

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including blood loss and recurrence of hemorrhage

18 months
Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Nebulized Tranexamic Acid

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Nebulized Tranexamic AcidExperimental Treatment1 Intervention
Group II: Nebulized SalinePlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials
486
Recruited
92,500+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+