Clinical Assessment of Thrombosis in Children After Heart Surgery: The CATCH Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Incidence of Thromboembolic Complications (TC) after pediatric cardiac surgery
研究概览
简要总结
Thromboembolic complications (TCs) are important causes of morbidity and mortality after pediatric cardiac surgery, resulting in longer hospital stay, increased risk of early and late post-surgical complications, early reoperation, neurologic and organ damage, and potentially death. The true incidence of blood clots in pediatric surgical patients is unknown.
The overarching objective of this study is to further our understanding of TCs, including quantification, characterization and risk stratification. This study will ultimately allow the development of effective tools for prevention and early identification of TCs, rather than focusing on treatment alone.
详细描述
There is very limited data on TCs associated with cardiac surgery in pediatric patients. The actual incidence of TCs in this context is not currently known reflecting a lack of clinical suspicion, reporting biases, and/or the use of inappropriate diagnostic tests
Pediatric cardiac surgery is associated with disruption of blood flow, platelet dysfunction and activation, and blood hypercoagulability; all of which are contributing to clot formation
All congenital heart defects are associated with blood flow disturbance but some are associated with more extreme disturbances. The investigators hypothesize that not all types of CHD repairs will be at the same risk of TCs based on the extent of blood flow disturbances they cause. The investigators hypothesize that line location, difficulties in line insertion, including multiple insertion attempts and longer duration of indwelling will be associated with increased risk of TCs.
Pediatric cardiac surgery is associated with inflammation and platelet activation, both of which are potent contributors to blood hypercoagulability: CPB presents a hemostatic challenge associated with an abundance of pro-thrombotic risk factors and an opposite presence of pro-hemorrhagic risk factors. The investigators hypothesize that factors associated with increased platelet activation and inflammation, and in consequence, greater laboratory values of markers of platelet activation and inflammation, will be associated with increased risk of TCs.
Coagulation system activity in children is immature, hyporeactive and exhibits a high degree of resistance to heparin and anticoagulation. The investigators theorize that lower levels of coagulation system activity, presence of high-risk genetic polymorphisms, greater CPB hemodilution, increased heparin requirement and lower blood heparin activity expressed by anti-factor X activity (anti-Xa) concentration during CPB and greater requirement for allogeneic blood will be associated for increased risk of TCs.
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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients scheduled for cardiac surgery requiring cardiopulmonary Bypass
排除标准
- •Known severe risk factors to thromboembolic complications
- •Active cancer
- •Congenital coagulopathy (e.g. haemophilia)
- •No planned cardiology follow-up at the Hospital for Sick Children
结局指标
主要结局
Incidence of Thromboembolic Complications (TC) after pediatric cardiac surgery
时间窗: Outcome will be recorded throughout the duration of the participants hospital stay, an expected average of 10 days
Thrombosis will be recorded through review of post-operative clinical assessments, targeted laboratory testing for blood abnormalities and echocardiographic/ultrasound evaluation.
次要结局
- Assessment of the patients' coagulation, hemostatic and inflammatory system activity(Baseline)
- Response of the patients coagulation, hemostatic and inflammatory system activity to cardiopulmonary bypass(Up to 10 days after surgery)
- Proportion of patients with thrombo-occlusive complications of thrombosis(18-24 months after surgery)
- Genome-Wide Association Study (GWAS)(Baseline)
- Post-thrombotic Syndrome (PTS) Evaluation(Up to 2 years after surgery)
- Post-operative sign and symptoms of thrombosis(Up to 10 days after surgery)
- Neurodevelopment and functional health assessment(Up to 2 years post- surgery)
研究者
Brian McCrindle
Staff Cardiologist
The Hospital for Sick Children