Comparison of the Effects of Conventional and Minimal Invasive Extracorporeal Circulation Systems on Coagulation Parameters in Open Heart Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Fibrinogen Concentration From Preoperative Baseline to 24 Hours After Surgery
研究概览
简要总结
The aim of this study is to compare the effects of conventional and minimally invasive extracorporeal circulation (MiECC) techniques, which are routinely used in open-heart surgery, on coagulation parameters.
详细描述
This prospective observational study compares conventional extracorporeal circulation with minimally invasive extracorporeal circulation (MiECC) in patients aged 30 to 70 years undergoing isolated coronary artery bypass grafting. The circulation method is selected as part of routine clinical care. The protocol plans 40 participants in each group (80 in total). Coagulation parameters, including fibrinogen concentration, platelet count, prothrombin time, activated partial thromboplastin time, and international normalized ratio, are assessed before surgery, immediately after surgery, and 6 and 24 hours after surgery. The primary comparison is the change in fibrinogen concentration from preoperative baseline to 24 hours after surgery between the two groups.
研究设计
- 研究类型
- 观察性
- 观察模型
- 队列研究
- 时间视角
- 前瞻性
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- Age 30 to 70 years.
- Undergoing isolated coronary artery bypass grafting.
- No known coagulopathy.
- No diagnosed advanced renal or hepatic failure affecting the coagulation profile.
排除标准
- Emergency surgery.
- Repeat cardiac surgery.
- Valve replacement surgery.
- Postoperative intra-aortic balloon pump use.
- Need for surgical revision.
- Advanced renal or hepatic failure.
- Inherited hematologic disease.
研究组 & 干预措施
Conventional Extracorporeal Circulation
Patients undergoing isolated coronary artery bypass grafting with conventional extracorporeal circulation, according to the clinical surgical plan.
干预措施: Conventional extracorporeal circulation (Procedure)
Minimally Invasive Extracorporeal Circulation
Patients undergoing isolated coronary artery bypass grafting with minimally invasive extracorporeal circulation (MiECC), according to the clinical surgical plan.
干预措施: Minimally invasive extracorporeal circulation (Procedure)
结局指标
主要结局
Change in Fibrinogen Concentration From Preoperative Baseline to 24 Hours After Surgery
时间窗: Preoperative baseline through 24 hours after surgery
Fibrinogen concentration is measured before surgery, immediately after surgery, and at 6 and 24 hours after surgery. The change from preoperative baseline to 24 hours is compared between the conventional extracorporeal circulation and MiECC groups.
次要结局
- Change in Platelet Count From Preoperative Baseline to 24 Hours After Surgery(Preoperative baseline through 24 hours after surgery)
- Change in Prothrombin Time From Preoperative Baseline to 24 Hours After Surgery(Preoperative baseline through 24 hours after surgery)
- Change in Activated Partial Thromboplastin Time From Preoperative Baseline to 24 Hours After Surgery(Preoperative baseline through 24 hours after surgery)
- Change in International Normalized Ratio From Preoperative Baseline to 24 Hours After Surgery(Preoperative baseline through 24 hours after surgery)
研究者
Umran Karaca
Assoc. Prof. of Anesthesiology and Reanimation
Bursa Yuksek Ihtisas Training and Research Hospital
研究点 (1)
标识符
- NCT 编号
- NCT07844031
- 其他研究编号
- BursaYIERH-AR-06
日期
- 首次提交
- (8天前)
- 首次发布
- (前天)
- 主要完成日期
- (12小时后)
- 研究完成日期
- (12小时后)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 是否有结果
- 否