Exposure of Salvaged Blood to Inflammation and Oxidative Stress: the Effect of Different Anticoagulant Regimes. Heparin vs Citrate in Cellsaver (HECICS).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- difference in concentration of pro- and anti-inflammatory markers and markers of oxidative stress in the cell-free fraction of the centrifugate of the unwashed autologous blood/anticoagulant mixture in the cell saver reservoir
研究概览
简要总结
The primary aim of this randomized controlled study is to determine whether the use Anticoagulant Citrate Dextrose Solution--Formula A (ACD-A) in cell salvage reduces inflammation and oxidative stress in cell saver blood compared to heparin. The secondary aim is to determine whether any differences in activation can be correlated to any differences in postoperative clinical outcome.
详细描述
The first primary outcome of this study is the difference in concentration of pro- and anti-inflammatory markers and markers of oxidative stress in the cell-free fraction of the centrifugate of the unwashed autologous blood/anticoagulant mixture in the cell saver reservoir, after correction for cardiopulmonary bypass (CPB) time up to the start of the first washing cycle and contact time of the anticoagulant (either ACD A or heparin) with the saved blood:
- total antioxidant status (TAS)
- Total thiols in proteins (TTP)
- oxidized LDL (oxLDL)
- Pro-inflammatory markers: interleukins (IL), IL-6, IL-8, myeloperoxidase (MPO)
- Anti-inflammatory marker: IL-10
The second primary outcome of this study is the difference in direct quality of the washed, salvaged red blood cells (RBC):
- Blood smear: evaluation by light microscopy
- Osmotic fragility
- Haemoglobin and hematocrit
- Free haemoglobin
- Free iron
- Lactate
- pH Confounding factors (CPB duration, contact time of anticoagulant with saved blood, time since first washing cycle in case of multiple washing cycles) will be controlled for.
Secondary outcome:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Elective cardiac revascularization surgery patients: subgroup analysis for
- •on pump coronary artery bypass grafting (CABG)
- •off pump CABG (OPCABG)
排除标准
- •Urgent procedures
- •Severe shock
- •Active infection
- •Inflammatory diseases
- •Active neoplasia
- •Immune suppressive drugs
- •Active or recent renal replacement therapy (RRT)
- •Anticoagulation or anti-aggregation therapy that hasn't been timely interrupted according to guidelines (12,13)
- •Need for allogenous blood transfusion before completion of data collection
- •Massive peroperative bleeding that cannot be safely managed while collecting study data
研究组 & 干预措施
citrate
A quantity of 20 ml ACD-A per 100 ml of collected blood is used to prevent coagulation in the cell savage process. Pre-prepared ACD-A solutions is available (composition of ACD-A solution used: 22.0 g sodium citrate dehydrate, 24.5 g glucose monohydrate, 8.0 g citric acid monohydrate per 1000 ml of water
干预措施: ACD-A (Drug)
heparin
A heparinised saline solution of 25,000 IU of heparin per 1 litre of intravenous normal saline (0.9% NaCl) solution is used with a dosage of 20 ml of solution per 100 ml of collected blood. This type of solution is not commercially available and is made locally. This solution is used in the cell salvage process to prevent coagulation.
干预措施: Heparin (Drug)
结局指标
主要结局
difference in concentration of pro- and anti-inflammatory markers and markers of oxidative stress in the cell-free fraction of the centrifugate of the unwashed autologous blood/anticoagulant mixture in the cell saver reservoir
时间窗: maximum 3 hours post-operatively
measurement of: TAS: total antioxidant status TTP: total thiols in proteins oxLDL: oxidized LDL Pro-inflammatory markers: IL-6, IL-8, myeloperoxidase (MPO) Anti-inflammatory marker: IL-10
次要结局
- The second primary outcome of this study is the difference in direct quality of the washed, salvaged RBC:(maximum 3 hours post-operatively)
研究者
Willem Boer
Consultant Intensivist
Ziekenhuis Oost-Limburg