iCHEC: Identifying Children with HEreditary Coagulation disorders
Research type
Research Study
Full title
iCHEC: Identifying Children with HEreditary Coagulation disorders
IRAS ID
221961
Contact name
C.J. Fijnvandraat
Contact email
Sponsor organisation
Emma Children's Hospital, Academic Medical Centre
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The aim of this study, which has been developed by a research team in The Netherlands, is to evaluate and improve a tool called the 'Paediatric Bleeding Assessment Tool'. This questionnaire helps to assess children and young people who have a problem with easy bruising and/or bleeding by asking a number of questions about their symptoms. The answers allow the calculation of a 'bleeding score', with a higher score correlating with more severe bleeding symptoms.
The study will involve 200 children and young people, aged <18 years, from haematology centres in the UK, Canada and The Netherlands. These participants will be selected as they have been referred for investigation of bruising or bleeding symptoms, an abnormal blood clotting test or for a family history of a bleeding disorder.
The research participant and/or their parent/carer will complete the questionnaire prior to being seen by the doctor in the clinic. They will then have their normal clinic consultation which will include the doctor taking a history of their bruising or bleeding symptoms and some blood tests to investigate their blood clotting system. They will not be having any extra blood tests for the purposes of the study.
Data will be collected on the participants' responses to the questionnaire, the history taken by the clinic doctor, the results of the blood tests and the presence or absence of a diagnosis of a bleeding disorder. These results will allow the investigators to decide whether the bleeding score predicts the diagnosis of a bleeding disorder and which of the questions are the most useful to 'rule in' or 'rule out' a bleeding disorder.
It is hoped that in the future, children with bruising or bleeding symptoms who have a low bleeding score may not need to undergo blood tests in order to decide whether they have a bleeding disorder.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
17/NW/0152
Date of REC Opinion
9 Mar 2017
REC opinion
Favourable Opinion