跳至主要内容
临床试验/NCT04241380
NCT04241380Unknown不适用

Anticoagulation Medicine in Surgical Repair for Total Anomalous Pulmonary Venous Connection: a Randomize Multi-centers Study

Guangdong Provincial People's Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年2月20日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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

Active Comparator

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

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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