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

Perth Children's Hospital0 个研究点目标入组 70 人开始时间: 2021年2月3日最近更新: 2023年5月1日

适应症

试验速览

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•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.

•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.

发起方

Perth Children's Hospital