STOP : Study of Tranexamic acid On Post Tonsillectomy haemorrhage

Phase 1

Recruiting

• Conditions: Emergency medicine - Other emergency care; Secondary post tonsillectomy haemorrhage; Surgery - Other surgery

• Registration Number: ACTRN12621000107820
• Lead Sponsor: Perth Children's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-03
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Patients age 3-16 years presenting to a tertiary paediatric emergency department within the hours of 0600-2400 with secondary post tonsillectomy haemorrhage (sPTH). sPTH is defined as bleeding onset more than 24hrs after initial tonsillectomy.

Exclusion Criteria

Initial Exclusion Criteria;
Any sPTH patient with an obvious Grade 4 bleed.
Any sPTH patient that appears pale, subdued or unwell looking.
Any sPTH patient with a HR or BP giving an early warning score of 3 on the local institution's Paediatric Acute Recognition and Response Observation Tool at the time of ED presentation.

Further Exclusion Criteria;
Any patient presenting with sPTH who has already received IV TXA or oral TXA as part of their treatment for that episode of sPTH. This may occur if they have transferred from a peripheral ED.

Patients with a known allergy or contraindication to TXA.

Patients with a history of severe asthma defined as previous ICU admission for asthma.

Patients with a prothrombotic condition including thromboembolism, deep venous thrombosis, stroke, or Kawasaki’s disease.

Patients with known renal impairment.

Patients with a seizure disorder

Patients with a known bleeding disorder

Patients who have previously been enrolled in this study

Patients with parents or carers who are judged to have a limited understanding of English and therefore, will not be able to participate in the deferred consent process.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure will be a change in bleeding grade, according to a modified version of the Stammberger classification of sPTH, measure 15 minutes after commencement of TXA treatment. <br><br>[Time Zero minutes (T0) - baseline bleeding grade using the modified Stammberger classification of sPTH taken at time 0 minutes during initial ED doctor assessment. Time Fifteen minutes (T15) - follow-up bleeding grade according to a modified Stammberger classification of sPTH, taken at time 15 minutes from the initial ED doctor assessment]