Assessment of the Usefulness of Hemopatch in Coronary Artery Bypass Graft Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Total postoperative drainage (ml)
研究概览
简要总结
The study aim is to assess polyethylene glycol (PEG) coated collagen patch (Hemopatch) on the quality of drainage after surgery, the length of hospital stay, the number of reoperations due to haemorrhage and treatment cost. The study will be conducted in 200 patients undergoing Coronary Artery Bypass Grafting (CABG) with the use of extracorporeal circulation and Internal mammary Artery (IMA) harvesting. Traditional method of haemostasis will be applied in 100 patients and Hemopatch will be additionally used in 100 subjects to prevent haemorrhage after IMA harvesting and sternum closure.
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
- None
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
- •coronary heart disease CHD (mammary harvesting)
- •informed consent
排除标准
- •any condition that exclude patient from standard CABG procedure
- •additional cardiac procedure to be conducted on subject in addition to CABG
研究组 & 干预措施
Intervention
First group of patients will undergo standard CABG procedure in CPB. In addition, two pieces of Hemopatch will be applied in one patient. One piece to improve hemostasis in the bed of left internal mammary artery (LIMA) harvesting and second piece of Hemopatch will be placed beneath the sternum.
干预措施: Medical Device Hemopatch-PEG-coated collagen patch (Device)
Control
Second group of patients will undergo standard CABG procedure in CPB only.
结局指标
主要结局
Total postoperative drainage (ml)
时间窗: measured 48 hours after surgery
total amount of blood in the chest drainage system (mediastinum, pericardium, right and left pleura)
need for blood transfusion (number of blood units transfused)
时间窗: measeured after surgery until hospital discharge (on avarage until 7th day after surgery)
the total amount of blood passed to the patient
The number of reoperations
时间窗: observed until 7 days after surgery
The necessity of performing retoractomy due to excessive drainage or cardiac tamponade
次要结局
- level of hemoglobin (g/dl)(after surgery until hospital discharge (on avarage until 7th day after surgery))
- length of Intensive Care Unit stay (h)(on average 48 hours after surgery)
- hospital stay (days)(after surgery until hospital discharge (on average until 7th day after surgery))
- treatment cost (USD)(from patient hospital admission to hospital discharge ( on average 8-10 days))