Impact of Cardiac Surgery With a Minimal Invasive Extracorporeal Circuit οn Coagulation: Data From Point of Care Testing With Thromboelastometry and Impedance Aggregometry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Change of Clotting Time
研究概览
简要总结
This study includes patients undergoing elective cardiac surgery on MiECC. Coagulation status is assessed with ROTEM (TEM International GmbH, Munich, Germany) and Platelet function with impedance aggregometry using the ROTEM-Platelet (TEM International GmbH, Munich, Germany).
详细描述
Last update: 24th October 2019, Thessaloniki, Greece
Study protocol Objective Abnormal platelet function remains one of the main causes of severe bleeding during cardiac surgery, especially in the era of widespread evolution in antiplatelet therapy as standard of care in cardiac surgery patients. Additionally, conventional cardiopulmonary bypass is identified as a significant attributor to pathophysiologic derangement in coagulation and platelet dysfunction, induced by prolonged contact of blood with foreign surfaces, severe haemodilution, hypothermia and systemic inflammatory response. Minimally invasive extracorporeal circulation (MiECC) reflects the technological progress in cardiopulmonary circuits and offers improved perfusion conditions. The multiple electrode platelet aggregometry analysis can be a useful point-of-care diagnostic tool, assessing platelet receptors inhibition and aggregation, thus providing real-time information perioperatively. Our objective is to investigate the potential protective effect of MiECC on coagulation and platelet function and postoperative bleeding in a series of patients undergoing cardiac surgery.
Design This is a prospective cohort study. 57 adult patients presented for elective cardiac surgery were recruited in the study. Informed consent was obtained by all patients. Exclusion criteria were defined as follows: unwillingness to participate, preoperative platelet count ⩽150 × 109/mm3, age <18 or >79 years, emergency procedure, redo surgery, a known coagulation disorder and inaccurate documentation of preoperative antiplatelet medication.
Methods All patients were managed by the same surgical team and anaesthesiologist. They all received general anaesthesia in accordance with our institutional protocol. A dose of 15mg/kg tranexamic acid was given at induction of anaesthesia and after protamine administration. Surgery was performed under normothermia using a standard median sternotomy and MiECC modular (Type IV) circuit was used in all patients during CPB. An activated clotting time (ACT) value >300sec was aimed for patients undergoing CABG and an ACT>400sec for all other valve or complex surgery. Reversal of heparin was accomplished with protamine at a heparin-protamine titration ratio of 0.75.
Preoperatively demographics, comorbidities, use of anticoagulants, antiplatelet medication were collected and intraoperatively type of operation, duration of CPB, duration of aortic cross-clamp, and heparin and protamine doses were recorded. Fibrinogen levels (mg/dL) were measured before surgery (baseline) and after arrival in the ICU. Postoperative bleeding at 12 and 24 hours, as defined according to the universal definition of bleeding, was recorded, as well as intraoperative and 24-hour transfusion requirements (including blood products or coagulation factors concentrates) and major adverse events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 79 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective cardiac surgery
排除标准
- •unwillingness to participate
- •preoperative platelet count ≤150 × 109/mm3
- •redo surgery
- •a known coagulation disorder
- •inaccurate documentation of preoperative anti-platelet medication.
结局指标
主要结局
Change of Clotting Time
时间窗: Sample 1: baseline, Sample 2: after aortic cross clamp off
A parameter of the EXTEM and FIBTEM test performed using Rotational Thromboelastometry (ROTEM delta,Tem Systems Inc., Munich, Germany). It is measured in seconds and was tested in two time points. Sample 1: baseline, upon admission in the operation room and Sample 2: after aortic cross clamp off.
Change of Clot Formation Time
时间窗: Sample 1: baseline, Sample 2: after aortic cross clamp off
A parameter of the EXTEM and FIBTEM test performed using Rotational Thromboelastometry (ROTEM delta,Tem Systems Inc., Munich, Germany). It is measured in seconds and was tested in two time points. Sample 1: baseline, upon admission in the operation room and Sample 2: after aortic cross clamp off.
Change of ADPtest of Impedance Aggregometry
时间窗: Sample 1: baseline, Sample 2': 20 minutes after heparin reversal
ADPtest was performed using impedance aggregometry. Results expressed with the area under the curve (AUC) and represent the area under the aggregation curve, from the start of the measurement until 6 minutes (test duration). AUC was recorded as Ohm × minutes for each test. Both tests were performed at two time points. Sample 1: baseline, upon admission in the operation room and Sample 2: 20 minutes after heparin reversal.
Change of TRAPtest of Impedance Aggregometry
时间窗: Sample 1: baseline, Sample 2': 20 minutes after heparin reversal
TRAPtest was performed using impedance aggregometry. Results expressed with the area under the curve (AUC) and represent the area under the aggregation curve, from the start of the measurement until 6 minutes (test duration). AUC was recorded as Ohm × minutes for each test. Both tests were performed at two time points. Sample 1: baseline, upon admission in the operation room and Sample 2: 20 minutes after heparin reversal.
Change of Maximum Clot Firmness
时间窗: Sample 1: baseline, Sample 2: after aortic cross clamp off
A parameter of the EXTEM and FIBTEM test performed using Rotational Thromboelastometry (ROTEM delta,Tem Systems Inc., Munich, Germany). It is measured in millimeters and was tested in two time points. Sample 1: baseline, upon admission in the operation room and Sample 2: after aortic cross clamp off.
次要结局
- Bleeding in the drainage at 24 hours postoperatively(24 hours after the end of the procedure)
- Morbidity(30 days)
- Transfusion requirements(perioperatively and during first 24h in ICU)
- Bleeding in the drainage at 12 hours postoperatively(12 hours after the end of the procedure)
- Mortality(30 days)
研究者
Eleni Argyriadou
Associate Professor
AHEPA University Hospital
