Retrograde Autologous Priming for Preserving Hemoglobin Peri-operatively With or Without Mannitol: A Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Feasibility Outcomes
研究概览
简要总结
Hemodilution reduces concentrations of blood constituents: concentration of hemoglobin, red blood cells (hematocrit), physiological ions and coagulation factors that can contribute to impaired hemostasis and increasing the risk of perioperative blood transfusions. This pilot study will assess the feasibility of a large RCT to evaluate 2 techniques for reducing hemodilution during cardiac surgery: 1) retrograde autologous priming and 2) intraoperative mannitol. The aim of this pilot trial is to demonstrate feasibility of a larger trial to evaluate whether retrograde autologous priming and/or mannitol are superior to conventional priming alone.
详细描述
The use of large volumes of artificial priming fluids is still very high in cardiac surgery for routine CABG surgery with cardiopulmonary bypass. The resulting hemodilution is deleterious for patients and often requires counter measures to maintain fluid balance during and after surgery. Retrograde autologous priming and mannitol are simple low-cost solutions to the problem of hemodilution but their effectiveness, either alone or in combination, is unclear due to a lack of high-quality evidence. RAPPER-MAN is a single-centre 2x2 factorial cluster randomized trial. Participants will be randomly assigned (1:1:1:1 ratio) to the intervention groups: 1) Retrograde autologous priming (≥600 mL) + mannitol (0.3 g/kg bolus), 2) Retrograde autologous priming (≥600 mL) alone, 3) Conventional priming + mannitol (0.3 g/kg bolus), and 4) Conventional priming alone. The primary outcome is the change in hemoglobin concentration during cardiopulmonary bypass. Retrograde autologous priming will be performed within 10 minutes before, and mannitol will be added to the venous reservoir of the CPB machine within 5 minutes before, the start of cardiopulmonary bypass. The results of the larger trial are expected to have broad implications for fluid management in cardiac surgery in Canada.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age.
- •Undergoing a first-time cardiac surgical procedure (i.e. isolated CABG, isolated single cardiac valve surgery or a combination of both or isolated ascending aorta replacement) with the use of cardiopulmonary bypass (CPB) and median sternotomy.
排除标准
- •Left ventricle ejection fraction <25%
- •Emergency surgery
- •History of bleeding disorder
- •Inherited thromboembolic or infective endocarditis (active)
- •Previous cardiac surgery
- •Severe renal impairment (serum creatinine >250 μmol/L)
- •Hemoglobin <80 g/L
- •Thrombocytopenia (<50,000 platelets per μL)
- •Expected circulatory arrest
- •Body weight ≤50 kg
- •Allergy to mannitol
- •Pregnancy or breast feeding
研究组 & 干预措施
Conventional priming alone
Participants will receive conventional priming alone.
干预措施: Conventional Priming (Procedure)
Retrograde autologous priming alone
Priming solution (≥600 mL) will be removed from the extracorporeal circuit within 10 minutes before the initiation of cardiopulmonary bypass. Priming solution may be removed from 3 locations within the extracorporeal circuit (i.e. arterial, venous and cardioplegia lines) as determined by the perfusionist team.
干预措施: Retrograde autologous priming (Procedure)
Retrograde autologous priming + mannitol
Priming solution (≥600 mL) will be removed from the extracorporeal circuit within 10 minutes before the initiation of cardiopulmonary bypass. Priming solution may be removed from 3 locations within the extracorporeal circuit (i.e. arterial, venous and cardioplegia lines) as determined by the perfusionist team. In addition, mannitol will be added as a bolus (0.3 g/kg) to the venous reservoir of the cardiopulmonary bypass machine within 5 min before the start of cardiopulmonary bypass.
干预措施: Retrograde autologous priming (Procedure)
Retrograde autologous priming + mannitol
Priming solution (≥600 mL) will be removed from the extracorporeal circuit within 10 minutes before the initiation of cardiopulmonary bypass. Priming solution may be removed from 3 locations within the extracorporeal circuit (i.e. arterial, venous and cardioplegia lines) as determined by the perfusionist team. In addition, mannitol will be added as a bolus (0.3 g/kg) to the venous reservoir of the cardiopulmonary bypass machine within 5 min before the start of cardiopulmonary bypass.
干预措施: Mannitol (Drug)
Conventional priming + mannitol
Participants will receive conventional priming. In addition, mannitol will be added as a bolus (0.3 g/kg) to the venous reservoir of the cardiopulmonary bypass machine within 5 min before the start of cardiopulmonary bypass.
干预措施: Mannitol (Drug)
Conventional priming + mannitol
Participants will receive conventional priming. In addition, mannitol will be added as a bolus (0.3 g/kg) to the venous reservoir of the cardiopulmonary bypass machine within 5 min before the start of cardiopulmonary bypass.
干预措施: Conventional Priming (Procedure)
结局指标
主要结局
Feasibility Outcomes
时间窗: Start to end of study recruitment, which is anticipated to take 20 weeks
Feasibility will be established in the pilot phase if all the following criteria are met: 1. Average recruitment rate of 7 patients per week. 2. Complete Hb data before and after cardiopulmonary bypass in 90% of patients. 3. Compliance of the research team members, OR staff and ward medical staff with the protocol of 90%.
Change in hemoglobin concentration during cardiopulmonary bypass
时间窗: Start to end of cardiopulmonary bypass
Change in arterial hemoglobin concentration during cardiopulmonary bypass
次要结局
- Change in hemoglobin concentration after cardiopulmonary bypass(Start of cardiopulmonary bypass to hospital discharge or 5 days maximum (whichever occurs first))
研究者
Andre Lamy
Cardiac Surgeon
Hamilton Health Sciences Corporation