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临床试验/NCT03063801
NCT03063801已完成不适用

Observational Retrospective Study on the Transfusional Management of the Patients With Congenital Heart Disease Carried Out in Adulthood.

Pierre Wauthy1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
1
主要终点
Blood loss during surgery

研究概览

简要总结

Surgeries of heart disease in adulthood can happen in two specific contexts:

  • either for an asymptomatic anomaly, possibly coupled with the onset of symptoms later in life and tardily diagnosed and surgically managed
  • either for a malformation treated in childhood and requiring a new intervention in adulthood. In recent years, the number of adult patients with congenital heart disease has been steadily increasing. Advances in diagnostic techniques and surgical treatments have enabled many children to reach adulthood. The number of these patients is now higher than the number of children with congenital heart disease. The number of these patients having had surgery in adulthood is also increasing.

Congenital cardiopathies are numerous, ranging from simpler pathologies such as inter-auricular or inter-ventricular communication, to much more complex pathologies such as situations of univentricular hearts. The surgical treatments of these congenital heart diseases are classified into three groups: initial palliative surgery, initial curative surgery or iterative surgery. Palliative surgery aims to improve the clinical tolerance of the patient to the conditions of his pathology or to prevent complications. The curative surgery restores the physiological circulation, the iterative surgery treats a complication or a degeneration appearing after a curative surgery.

Patients undergoing cardiac surgery frequently receive blood products transfusions during the preoperative, intraoperative, or postoperative periods. Several observational studies have shown that in cardiac surgery, the transfusion of blood derivatives is associated with an increase in post-operative morbidity and mortality.

The objective of this study is to analyze the predictive factors of transfusion in congenital patients operated in adulthood at Brugmann University Hospital, depending on the type of surgery applied (palliative, curative or iterative). The secondary objective will be to assess whether there are any differences with the predictive factors identified in non-congenital patients undergoing cardiac surgery, which could potentially alter the transfusion approach in congenital patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Cardiac surgery linked to the presence of a heart congenital malformation.

排除标准

  • •Transfusion refusal from the patient

结局指标

主要结局

Blood loss during surgery

时间窗: 10 years

Blood loss during surgery

Co-morbidities

时间窗: 10 years

List of co-morbidities (descriptive analysis)

Type of surgery

时间窗: 10 years

Type of cardiac surgery

Demographic data

时间窗: 10 years

Demographic characteristics of the patients (descriptive analysis)

Complications during surgery

时间窗: 10 years

Complications during surgery: descriptive analysis

Complications after surgery

时间窗: 10 years

Complications after surgery: descriptive analysis

次要结局

未报告次要终点

研究者

发起方
Pierre Wauthy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Pierre Wauthy

Head of clinic

Brugmann University Hospital

研究点 (1)

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