Scanning Electron Microscopy (SEM) and Confocal Imaging of Clot in Two Different Protamine Environments (PrOtamIne doSing clOt imagiNg (POISON) Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- High-resolution microscopic images (Scanning Electron Microscopy and Confocal Imaging)
研究概览
简要总结
The proposed study involves using two different high-resolution microscopic imaging techniques to examine the health and platelet invasion of clot in patients who were given 1:1 protamine / heparin and compare this to clot from patients who had heparin reversed using the PRODOSE algorithm. Patients will be treated according to the routine clinical practice of their individual care team.
详细描述
Sample collection at RPH
Patients will have a total of 14ml of blood taken during the procedure.
The first 7ml will be taken after induction of anaesthesia along with routine blood gas and coagulation sampling through the routinely indwelling arterial catheter. The initial sample must be taken before any heparin has been administered. This will be used to fill 2 x 3.5ml citrated (green top) blood tubes. These will be clearly labelled as "pre-heparin" with a Tissue Bank ID number.
The second 7ml will be taken 5 minutes after heparin has been reversed with protamine after cessation of cardiopulmonary bypass. It will again be taken at the same time as routine sampling for blood gas and coagulation studies. Analog to the first sample, it will again be divided and used to fill 2 x 3.5ml citrated (green top) blood tubes. These will be clearly labelled as "post-protamine" with the same ID number and whether "1:1" or a "PRODOSE algorithm determined" protamine: heparin ratio was used.
In keeping with clinical routine, ROTEM coagulation testing and full blood counts will be requested as seen necessary by the clinical team.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •undergoing elective, uncomplicated single procedure cardiac surgery with anticipated CPB duration < 120 min
- •with all anticoagulant drugs stopped at least 5 days before surgery, apart from aspirin
- •with normal full blood count and clotting screen pre-OP.
排除标准
- •emergency surgery
- •inability to stop anticoagulants except aspirin for 5 days pre-OP
- •complex surgery with anticipated CPB duration > 120min
- •operations planned to be done at temperature on CPB < 34 degrees
- •operations requiring deep hypothermic circulatory arrest, solid organ transplantation
- •know blood dyscrasia
- •intra-operative blood or blood product transfusion or post-operative coagulopathy
结局指标
主要结局
High-resolution microscopic images (Scanning Electron Microscopy and Confocal Imaging)
时间窗: Pre Heparin and Post Protamine [5 minutes after heparin has been reversed]
The proposed study involves using two different high-resolution microscopic imaging techniques to examine the health and platelet invasion of clot in patients who were given 1:1 protamine / heparin and compare this to clot from patients who had heparin reversed using the PRODOSE algorithm. This is an observational study in which differences between images of clot obtained from samples from the two patient groups and before and after cardiopulmonary bypass will be described.
次要结局
未报告次要终点