Intermittent antegrade warm blood versus cold blood cardioplegia in children undergoing open heart surgery: a randomised controlled trial (THERMIC-3)

niversity Hospitals Bristol NHS Foundation Trust0 个研究点目标入组 97 人开始时间: 2018年4月5日最近更新: 2023年3月6日

适应症

试验速览

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33055113/ protocol (added 22/10/2020) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36799559/ (added 20/02/2023)

•Patients undergoing a congenital heart operation requiring CPB and cardioplegic arrest at the BRHC

•1. Patient weighing < 3 kg
•2. Patient requires an emergency operation (patient with haemodynamic instability who require immediate surgical intervention defined as operation within 24 hours of admission)
•3. Patient requires secundum atrial septal defect repair (ASD) as an isolated procedure
•4. Patient judged pre-operatively by surgeon to require deep hypothermic circulatory arrest (e.g. aortic arch repair, repair of total anomalous pulmonary venous drainage (TAPVD), Norwood procedure)
•5. Patient judged pre-operatively by the surgeon to require deep hypothermic CPB
•6. Patient judged by the surgeon pre-operatively to be too complex. This could be procedure related or patient related (e.g. complex tailor made surgery; necrotising enterocolitis; pre-operative brain haemorrhage; or generalised bleeding state/ongoing major bleeding)
•7. Patient of consenting/assenting age lacking capacity to consent/assent
•8. Patient under the care of social services and/or parent/guardian unavailable for consent
•For the sub-study, the following additional exclusion criteria will apply:
•9. Patient aged < 4 months
•10. Patient weighing < 6 kg
•11. Patient has contraindication for urethral catheterisation due to urethral obstruction or haemorrhage.

发起方

niversity Hospitals Bristol NHS Foundation Trust