ISRCTN13638147进行中（未招募）未知
del Nido versus St. Thomas’ blood cardioplegia in the young (DESTINY) trial: a multi-centre randomized controlled trial in children undergoing cardiac surgery
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Children (<16 years) undergoing cardiac surgery on cardiopulmonary bypass with cardioplegic arrest
排除标准
- •Current exclusion criteria as of 14/03/2024:
- •1. Predicted cross-clamp time <30 minutes (e.g. atrial septal defect, atrial septectomy, sub-aortic stenosis) at the discretion of the Consultant surgeon
- •2. Known contraindication to one of the constituents of either cardioplegia solution (e.g. lidocaine/procaine hypersensitivity/allergy) or its method of delivery, including temperature (e.g. haemoglobinopathy including sickle cell disease, cold agglutinins)
- •3. Ventricular assist device (VAD) insertion/explant or transplantation
- •4. Pre-operative inotropic support or extracorporeal life support (ECLS)
- •5. Previous cardiac surgery with cardioplegic arrest within the last 30 days
- •6. Previous enrolment in the DESTINY trial
- •7. Emergency surgery
- •8. Parent/guardian declines consent
- •9. Weight at the time of surgery >50kg
- •Previous exclusion criteria:
- •1. Predicted cross-clamp time <30 minutes (e.g. atrial septal defect, atrial septectomy, sub-aortic stenosis) at the discretion of the Consultant surgeon
- •2. Known contraindication to one of the constituents of either cardioplegia solution (e.g. lidocaine/procaine hypersensitivity/allergy) or its method of delivery, including temperature (e.g. haemoglobinopathy including sickle cell disease, cold agglutinins)
- •3. Ventricular assist device (VAD) insertion/explant or transplantation
- •4. Pre-operative inotropic support or extracorporeal life support (ECLS)
- •5. Previous cardiac surgery with cardioplegic arrest within the last 30 days
- •6. Emergency surgery
- •7. Parent/guardian declines consent
- •(added 15/03/2023)
- •8. Weight at the time of surgery >50kg
- •9. Previous enrolment in the DESTINY trial
研究者
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