RecruitingPhase 2ACTRN12621000107820

STOP : Study of Tranexamic acid On Post Tonsillectomy haemorrhage

STOP : Study of Tranexamic acid On Post Tonsillectomy haemorrhage in children and adolescents

Sponsor

Perth Children's Hospital

Enrollment

70 participants

Start Date

Oct 22, 2022

Study Type

Interventional

Conditions

Secondary post tonsillectomy haemorrhage

Summary

STOP is intended to be a small pilot study conducted in a specialised paediatric emergency department (ED) examining the effect of giving the medication tranexamic acid or 'TXA' via a nebuliser on children aged 3-16y ears who come to the ED with throat bleeding after tonsillectomy surgery. We intend to study whether nebulised TXA is a safe and effective alternative to intravenous TXA, which is currently part of the standard treatment for this condition in the institution involved. Each child presenting to our ED with bleeding following tonsillectomy surgery will be screened for suitability, considered for enrolment and approached for consent to participate. Half of the patients will be allocated to a single initial dose of nebulised TXA and half will be allocated the standard single dose intravenous TXA treatment. We will grade the severity of bleeding from the throat on each patient firstly on their arrival to the ED and again 15 minutes after the TXA has been administered. We will also capture data concerning the timing of treatment, the acceptability and tolerance to nebulised TXA for this condition and information regarding the patient's episode of hospital care. The results will help us understand whether nebulised TXA is tolerated, easy to administer, its safety profile and its impact on post tonsillectomy bleeding in comparison to IV TXA treatment. We will also seek to establish if there is any evident differences in subsequent hospital stay and medium term adverse effects.

Eligibility

Sex: Both males and femalesMin Age: 3 YearssMax Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

One of the more frightening complications that can occur after a child's tonsil removal (tonsillectomy) is bleeding from the throat — known as secondary post-tonsillectomy haemorrhage — which can happen several days after the surgery. When this occurs, children are brought to the emergency department and currently treated with tranexamic acid (TXA), a medication that helps blood clot, given through a drip (intravenously). This pilot study is testing whether TXA delivered through a nebuliser (a mist that is breathed in) works just as well as the intravenous version — and is better tolerated — in children aged 3–16. Nebulised TXA is simpler to administer and avoids the distress of a needle for young children. The study compares bleeding severity before and after each treatment, how easy the treatment is to give, and whether there are any side effects. Children aged 3–16 who present to Perth Children's Hospital with throat bleeding more than 24 hours after their tonsillectomy are potentially eligible. Children who are very unwell on arrival, have active severe bleeding, have previously received TXA for this episode, or have seizure disorders, bleeding disorders, or severe asthma are excluded.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

A single dose of nebulised tranexamic acid (nTXA) for patients (aged 3-16 yrs) presenting to the emergency department (ED) with a case of secondary post tonsillectomy haemorrhage (sPTH). The solution

A single dose of nebulised tranexamic acid (nTXA) for patients (aged 3-16 yrs) presenting to the emergency department (ED) with a case of secondary post tonsillectomy haemorrhage (sPTH). The solution for injection form of tranexamic acid (100mg/ml) will be used and administered via a nebuliser. The dose will be 250 mg for patients weighing less than or equal to 25 kg and 500 mg for patients weighing more than 25 kg. The nebulised dose of TXA will be given in lieu of a single intravenous dose of TXA which is our current standard management for sPTH in the ED at the study site. Adherence to the intervention will monitored in a number of ways. The allocated study pack will be bundled with the study data collection form (CF). This will provide clear guidance on which form of TXA is to be given and will provide a source of documentation. Medical records including ED medical notes, ED nursing notes and medication charts will also provide sources to verify method and dose of TXA administration.

Locations(1)

WA, Australia

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ACTRN12621000107820