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TEAPOT Study Multisite (TEAPOT)

21. maj 2026 opdateret af: Andrew D. Meyer, The University of Texas Health Science Center at San Antonio

TranExamic Atomized for Pediatric Post-Operative Tonsillectomy Hemorrhage (TEAPOT): A Multi-center Feasibility Study

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The study intervention involves administering nebulized tranexamic acid (TXA) to pediatric patients with traumatic hemorrhage (PTH). The intervention consists of three consecutive doses of nebulized TXA.

The dosage of nebulized TXA is adjusted based on the child's weight. For children weighing more than 25 kg, each dose is 500 mg. For children weighing less than 25 kg, each dose is 250 mg.

Frequency: The three doses of nebulized TXA are administered consecutively over the course of approximately an hour. Administration Method: Nebulized TXA is delivered through a nebulizer device. A nebulizer converts the liquid medication into a fine mist or aerosol, which is then inhaled by the patient. This method allows the medication to be delivered directly to the respiratory tract, where it can exert its effect on the bleeding site. Delivery Setting: The intervention may take place in a clinical setting, such as a hospital or outpatient clinic, where nebulizer devices and medical supervision are readily available. Each patient receives three nebulized independent doses of TXA in succession. The delivery of the intervention is carried out by healthcare professionals trained in administering nebulized medications.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

30

Fase

  • Tidlig fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • California
      • Davis, California, Forenede Stater, 95819
        • University of California at Davis Medical Center
        • Kontakt:
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02903
        • Hasbro Childrens' Hospital
        • Kontakt:
    • Texas
      • San Antonio, Texas, Forenede Stater, 78229
        • University Hospital
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Received a tonsillectomy
  2. Presents to the ED with secondary* post-tonsillectomy hemorrhage
  3. Children between age of 2 to 17 years of age (i.e., before their 18th birthday) *Secondary post-tonsillectomy hemorrhage is defined as greater than 24 hours from their primary tonsillectomy operation (arrival in recovery/PACU).

Exclusion Criteria:

  1. Known and documented bleeding or clotting disorder.
  2. Known pregnancy.
  3. Patients with known hypersensitivity or allergic response to tranexamic acid.
  4. Parents or guardians who cannot communicate in English or Spanish.
  5. Intubation prior to enrollment.
  6. Previously enrolled patients.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Forstøvet tranexamsyre
Forsøgspersoner vil blive administreret forstøvet TXA post-tonsillektomi, hvis de vender tilbage til skadestuen med blødning efter operationen
Medicin: Tranexamsyre injicerbart produkt
Deltagerne vil modtage tre doser TXA 500 mg (5 mL TXA 100 mg/ml) forstøvet med en PARI LC D engangsforstøver eller tilsvarende over 10-15 minutter ved brug af 8 eller mere liter/minut gasflow.
Andre navne:
  • TXA 100mg/ml
Placebo komparator: Forstøvet saltvand
Forsøgspersoner vil blive administreret forstøvet saltvand post-tonsillektomi, hvis de vender tilbage til skadestuen med blødning efter operationen
Andet: Normal saltvand
Deltagerne vil modtage tre 5 ml doser placebo (normalt saltvand) forstøvet med en PARI LC D engangsforstøver eller tilsvarende i løbet af 10-15 minutter ved brug af 8 eller mere liter/minut gasflow.
Andre navne:
  • 0,9% saltvandsopløsning

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Indirekte lokal koncentration af forstøvet TXA
Tidsramme: Umiddelbart efter forstøverbehandling (inden for 60 minutter) og derefter inden for 8 timer.
Begrænsede data om forstøvet TXA systematisk absorption. Topiske PK-undersøgelser af TXA dokumenterer en signifikant reduktion i systematiske niveauer, men den samme hæmostase-effekt. Indsamling af to blodprøver fra hver deltager. Dette vil verificere en lungefysiologisk-baseret PK-model (PBPK) (dvs. næsehule, svælg og lunge), der indirekte forudsiger den oropharyngeale og systematiske koncentration af forstøvet TXA.
Umiddelbart efter forstøverbehandling (inden for 60 minutter) og derefter inden for 8 timer.
Systemisk koncentration af forstøvet TXA
Tidsramme: Umiddelbart efter forstøverbehandling (inden for 60 minutter) og op til otte timer.
Farmakokinetiske prøver vil blive indsamlet efter afslutning af den sidste forstøvede behandling modtaget inden for tres minutter. Et andet tidspunkt bør derefter indsamles efter tres minutter op til otte timer fra sidste forstøver, adskilt fra det foregående tidspunkt med mindst tres til halvfems minutter. Serum-TXA-niveauerne vil blive brugt til at verificere en TXA Fysiologisk-baseret farmakokinetisk model og bestemme populationsvariabiliteten. Denne PBPK-model er bygget af vores forskningsfarmaceut baseret på omfattende forskning, der allerede er gennemført om TXA-distribution og metabolisme. Når modellen er bygget, behøver efterforskerne kun en til to prøver for at afgøre, om modellen nøjagtigt afspejler indsamlede prøver. Efterforskerne vil udvikle en basismodel for at bestemme den bedst egnede kompartmentmodel, distribution og eliminationskinetik. Efterforskerne vil også bruge stokastiske modeller til at evaluere variabiliteten mellem individer i PK-parametre.
Umiddelbart efter forstøverbehandling (inden for 60 minutter) og op til otte timer.
Number of patients enrolled per month
Tidsramme: Baseline to 18 months (or duration of study approximately 18 months)
Assess target enrollment of patients per site per month.
Baseline to 18 months (or duration of study approximately 18 months)
Number of nebulizations per patient
Tidsramme: Baseline to 18 months (or duration of study approximately 18 months)
Evaluate the ability to nebulize at least two doses of TXA to children with PTH
Baseline to 18 months (or duration of study approximately 18 months)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Anslået blodtab
Tidsramme: Baseline til 7 dage
Bestem det estimerede blodtab pr. deltager
Baseline til 7 dage
Number of return visits to the OR
Tidsramme: Baseline to 18 months (or duration of study approximately 18 months)
The need for return to the Operating Room (OR) for surgical management of PTH) will be followed for up to seven days after randomization
Baseline to 18 months (or duration of study approximately 18 months)
Number of recurrences of PTH
Tidsramme: Baseline to 18 months (or duration of study approximately 18 months)
Number of participants in which there was a recurrence of post-tonsillectomy hemorrhage after the study drug was administered
Baseline to 18 months (or duration of study approximately 18 months)
Number of blood transfusions required
Tidsramme: Baseline to 18 months (or duration of study approximately 18 months)
Blood product transfusion volume will be measured at discharge or 24 hours (whichever comes first). This will include the volume of packed red blood cells, platelets, plasma, cryoprecipitate, or whole blood. Any mention of blood loss in electronic health records from emergency, anesthesiology, or surgeons' notes will be recorded.
Baseline to 18 months (or duration of study approximately 18 months)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Wong-Baker FACES Pain Rating Scale or FLACC (Face, Legs, Activity, Cry, Consolability) Score
Tidsramme: Day 7 after randomization (plus or minus one day)

Admission of this pain scale will be age dependent, but yields the same score for the patient selection of pain or the visual cues available for pain assessment by the study team.

Wong-Baker FACES Pain scale:

The participant rates their pain from 0=No hurt to 10=Hurts worst, with a higher score indicating greater pain.

FLACC Score:

Scores 5 items from 0-2 with a total possible score of 10. A higher score indicates more pain.
Day 7 after randomization (plus or minus one day)
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety scale for Adults
Tidsramme: Day 7 after randomization (plus or minus one day)
The PROMIS Anxiety Short Form 8a is scored by summing responses to 8 items, each rated on a 5-point scale (1=Never to 5=Always) over the past 7 days, resulting in a raw score range of 8 to 40. Higher scores indicate greater anxiety severity.
Day 7 after randomization (plus or minus one day)
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety scale for Children
Tidsramme: Day 7 after randomization(plus or minus one day)
The PROMIS Anxiety Short Form 8a is scored by summing responses to 8 items, each rated on a 5-point scale (1=Never to 5=Always) over the past 7 days, resulting in a raw score range of 8 to 40. Higher scores indicate greater anxiety severity.
Day 7 after randomization(plus or minus one day)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The University of Texas Health Science Center at San Antonio

Samarbejdspartnere

National Heart, Lung, and Blood Institute (NHLBI)

Efterforskere

  • Ledende efterforsker: Andrew D Meyer, MD, MS, The University of Texas Health Science Center at San Antonio

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

30. september 2027

Studieafslutning (Anslået)

30. september 2028

Datoer for studieregistrering

Først indsendt

27. april 2026

Først indsendt, der opfyldte QC-kriterier

27. april 2026

Først opslået (Faktiske)

4. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. maj 2026

Sidst verificeret

1. januar 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • IRB# 00191036
  • R34HL177446 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results in Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results in information from this trial will be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals.

IPD-delingstidsramme

Data from this study may be requested by other researchers 3 years after the completion of the primary endpoint by contacting Andrew D. Meyer, MD, MS or through the DCC public use dataset website.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Blødning, Kirurgisk

Kliniske forsøg med Tranexamsyre injicerbart produkt

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Dominican Republic

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner