Anticoagulation Medicine in Surgical Repair for Total Anomalous Pulmonary Venous Connection: a Randomize Multi-centers Study
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Incidence of postoperative pulmonary venous obstruction (PVO)
研究概览
简要总结
Total anomalous pulmonary venous connection (TAPVC) is a complex congenital heart disease, requiring surgical repair. Pulmonary venous obstruction (PVO) is the major complication, with limited effective reinterventions and poor outcomes. This trial aims at investigating that postoperative anticoagulant management reduce the incidence of PVO.
详细描述
Total anomalous pulmonary venous connection (TAPVC) is a complex congenital heart disease, with all the pulmonary veins connecting to the right heart system through collateral vessels, accounts for about 3% of congenital heart disease. Pulmonary venous obstruction (PVO) is a major complication, with limited effective reinterventions and poor outcomes. The major challenge for surgical repair of TAPVC is to lower the incidence of PVO.
Previous studies in our center showed the abnormal coagulation function, such as elevated International Normalized Ratio (INR), and decreasing of prothrombin activity, are associated with a higher rate of PVO. Some researches suggested that postoperative application of anticoagulants might reduce the incidence of PVO, however, the evidences are still limited. This trial will randomize patients to receive either conventional postoperative management or continuous infusion anticoagulant (Heparin) until the removal of deep vein catheter. The primary endpoint will be incidence of PVO, days of chest drainage more than 40ml/d, and mortality rate. Secondary endpoints including readmission, functional capacity assessment, quality of life and incidence of complications will also be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- — 至 1 Year(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants and neonates who are diagnosed with TAPVC
- •Infants and neonates who undergo initial surgical repair for TAPVC
排除标准
- •Concommitant diagnosis including functional single ventricular, double outlet right ventricle, tricuspid atresia, pulmonary atresia or transposition of the great arteries.
- •Older than 1-year-old.
研究组 & 干预措施
Conventional treatment group
Patients in this group will received conventional treatments. Drug: None. Drug: For the high-risk patients, doctors will assess their risk factors and choose continuous infusion heparin (initial dose 10 iu/kg/h and dynamic regulation until the activated coagulation time (ACT) 160-180 s) if needed. Aspirin 5 mg/kg may be given every eight hours subsequently for 3 months.
干预措施: No anticoagulant solutions (Other)
Conventional treatment group
Patients in this group will received conventional treatments. Drug: None. Drug: For the high-risk patients, doctors will assess their risk factors and choose continuous infusion heparin (initial dose 10 iu/kg/h and dynamic regulation until the activated coagulation time (ACT) 160-180 s) if needed. Aspirin 5 mg/kg may be given every eight hours subsequently for 3 months.
干预措施: Anticoagulant management (Drug)
Anti-coagulant treatment
Continuous infusion heparin. Patients in this group will received continuous infusion heparin 6 hours postoperatively (initial dose 10 iu/kg/h, dynamic regulation according to ACT 160-180s). After the removal of deep vein catheter, aspirin 5mg/kg will be given every eight hours subsequently for three months. Study will follow the intention-to-treat principle.
干预措施: Anticoagulant Solutions (Drug)
结局指标
主要结局
Incidence of postoperative pulmonary venous obstruction (PVO)
时间窗: 2 years
The postoperative PVO were diagnosed by echocardiography or computed tomography scan
Mortality rate
时间窗: 2 years
Inhospital or during follow-up, exclude the discharge from hospital against doctors' suggestions.
Days of chest drainage
时间窗: 2 years
\> 40ml/d, assessed during inhospital stay
次要结局
- Level of coagulation indexes.(2 years)
- Change in resting oxygen saturation(2 years)
- Value of tricuspid annular plane systolic excursion(2 years)
- Level of brain natriuretic peptide (BNP)(2 years)
