The ABC Trial - Does All-Blood Cardioplegia Prevent Blood Transfusion in Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Blood transfusion
研究概览
简要总结
This study is a single centre pilot for a randomized trial comparing all-blood cardioplegia to more dilute 4:1 blood cardioplegia during cardiac surgery. The hypothesis is that all-blood cardioplegia will be associated with less blood transfusion and better cardiac function.
详细描述
This is a single centre randomized, double blind, 2 arm, parallel group pilot study comparing all-blood cardioplegia to 4:1 blood cardioplegia in patients undergoing cardiac surgery. This pilot study will support the design of a larger multicentre trial.
Subjects undergoing cardiac surgery will be randomized to receive either standard of care (4:1) or all-blood cardioplegia for myocardial protection. Neither of these cardioplegia approaches would be considered investigational. Each is in use at numerous cardiac surgical centres around the world. The cardioplegia will be delivered using the Quest medical MPS system which is a Health Canada Approved device.
Clinical endpoints will be evalauted (rate of blood transtransfusion, ICU stay, etc...). In a subset of subjects who meet specific criteria, ventricular function will be evaluated in the operating room using the CD Leycom INCA conductance catheter system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients (male and female) undergoing isolated coronary artery bypass grafting,
- •isolated aortic or mitral repair or replacement, and
- •combined aortic or mitral valve repair or replacement and
- •coronary bypass grafting
排除标准
- •reoperation,
- •endocarditis,
- •dialysis dependant renal failure,
- •pre-operative ECMO or LVAD support,
- •contraindication to blood transfusion (ie. Jehovah's Witness), and
- •use of irreversible anti-platelet (other than ASA) and anticoagulant agents within 48h (ie. plavix, dabigitran, GpIIb/IIIa inhibitors, argatroban).
研究组 & 干预措施
Control
Patients receive standard 4:1 cardioplegia for myocardial protection during cardiac surgery
干预措施: Standard cardioplegia (Procedure)
Treatment
Patients receive all-blood cardiolpegia for myocardial protection during surgery
干预措施: All-blood cardioplegia (Other)
结局指标
主要结局
Blood transfusion
时间窗: 30 days
Number of units of packed red blood cells transfused
Intra-op diastolic function
时间窗: day 1
Left ventricular chamber stiffness constant measured by conductance catheter in the operating room
次要结局
- Troponin(24 hours post op)
- Volume of crystalloid delivered in cardioplegia(day 1)
- Fluid balance(30 d)
- Reoperation rate for bleeding(30 days)
- Inotrope score(30 day)
- Low output syndrome(30 days)
- Length of stay - hospital(30 day)
- intra-op Ventricular function(day 1)
- Lowest post op Hgb(30 days)
- Mortality(30 day)
- Duration of Ventilation(30 day)
- Lentgh of stay ICU(30 days)
- Other blood product administration(30 day)
- Hgb - arrival ICU(day 1)
- Hgb - prior to Discharge(30 days)
- Infection(30 days)
研究者
Pam Trenholm
Principal Investigator
Nova Scotia Health Authority