The Coagulum Study - Version 1.0
Research type
Research Study
Full title
A national mixed methods study to evaluate whether out of hospital oral anticoagulation programs for children and young people with congenital heart disease are safe, high quality and effective.
IRAS ID
241475
Contact name
Elisabeth Smith
Contact email
Sponsor organisation
Division of Research and Innovation
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Every week in the United Kingdom approximately 80 babies are born requiring a heart operation. Development of improved surgical and interventional skills, has improved outcomes for this patient group, resulting in an increasing population with a clinical need for oral anticoagulation (warfarin) within a structured care pathway and defined service provision, once discharged home.
After their operation some children and young people (CYP) need to take a medication by mouth every day for the rest of their life to stop their blood clotting, but the medication (warfarin) can also be dangerous. If a CYP has too much warfarin they may bleed; if they do not have enough their blood may clot, causing irreversible organ damage. We do not know the national number of cases in England, or the range of complications they experience. There is a lack of knowledge about their experiences once they leave hospital.
There are two main ways to monitor treatment effectiveness. They either attend a hospital clinic for a blood test, or a finger prick test at home using a patient self-testing (PST) machine, a health professional will then adjust treatment depending on the blood results. There is no current information about the experiences and views of CYP taking warfarin at home or the challenges of their families or health professionals. We also do not have their story around the burden of care of non-medical costs once discharged home.
This study will use a range of methods in three phases, including a national audit, interviews with children and young people, families and health professionals as well a national questionnaire. The research study has been developed in collaboration with a children and young peoples advisory group and a clinical expert group. The Biomedical Research Centre at Great Ormond Street Hospital for Children NHS Trust has funded this study.
REC name
London - Queen Square Research Ethics Committee
REC reference
19/LO/0906
Date of REC Opinion
24 Oct 2019
REC opinion
Further Information Favourable Opinion