"Point-Of-Care" Evaluation of Hemostasis in Children With Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Hemostasis measured by thromboelastometry and impedance aggregometry in cyanotic children
研究概览
简要总结
The purpose of this study is to assess coagulation and platelet function in children with congenital heart disease, measured with a bedside device (thromboelastometry and impedance aggregometry).
The investigators also aim to determine if this device detect post-cardiopulmonary bypass clotting derangements and may help to manage bleeding in this population.
详细描述
Hemostasis, a main concern during and after any surgical procedure, is traditionally monitored by the following laboratory tests: activated Partial Thrombin Time (aPTT), prothrombin time (PT), fibrinogen, platelets count. They neither provide a reliable estimate of the risk of bleeding, nor allow determining useful interventions.
New investigations of hemostasis are now used and validated during and after surgery: Rotational Thromboelastometry (ROTEM®) and impedance aggregometry. This is a quick bedside functional analysis of the patient's clotting. Children who undergo surgery under cardiopulmonary bypass (CPB) are particularly at risk of bleeding and this population hasn't been studied with large cohort yet.
Hypothesis: Hemostasis in children with CHD, especially when cyanotic, is intrinsically abnormal. The corrective surgery on CPB induces further hemostatic disorders which can be identified by the ROTEM platelet®.
The aim of the study is to evaluate the hemostatic function of the child with congenital heart disease using a Point-Of-Care (platelet-ROTEM ®) system, before surgery and after alterations induced by cardiopulmonary bypass (CPB).
This is a single center, observational, prospective study. Expected duration: 2 years. The investigators plan to include 200 patients with CHD, 100 patients undergoing surgery with CPB and 100 patients with congenital heart disease requiring cardiac catheterization. Recruitment will be conducted by the Division of Paediatric Cardiology.
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
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children between 0 and 16 years, born with a congenital heart disease requiring either cardiac catheterization or surgery with cardiopulmonary bypass
- •parental and/or patient consent
排除标准
- •known hemostatic disorder
- •known platelet function disorder
- •antiaggregation treatment <10 days before blood sampling
- •oral anticoagulation <2 days before blood sampling
- •intravenous heparin <6 hours before blood sampling
- •patient and parents unable to consent
结局指标
主要结局
Hemostasis measured by thromboelastometry and impedance aggregometry in cyanotic children
时间窗: Single measurement, during general anesthesia, immediately before procedure, when arterial line available
Hemostasis measured by thromboelastometry and impedance aggregometry
时间窗: Single measurement, during general anesthesia, immediately before procedure, when arterial line available
次要结局
- Thromboelastometry and impedance aggregometry changes after cardiopulmonary bypass (CPB)(maximum 3 measurements, during surgery and up to 6 hours after end of CBP)
- Thromboelastometry and impedance aggregometry changes in children with significant bleeding after CPB(Single measurement, during general anesthesia, immediately before procedure, when arterial line available)
研究者
David Longchamp
PICU consultant, MD
Centre Hospitalier Universitaire Vaudois