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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
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 5 mg/kg will be given every eight hours subsequently for 3 months.
They will receive non-coagulant or coagulant treatment according to clinical conditions.
Continuous infusion heparin (initial dose 10 iu/kg/h and dynamic regulation until the activated coagulation time (ACT) 160-180 s) for a few days. Aspirin 5 mg/kg will be given every eight hours subsequently for 3 months.
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
RECRUITINGIncidence of postoperative pulmonary venous obstruction (PVO)
The postoperative PVO were diagnosed by echocardiography or computed tomography scan
Time frame: 2 years
Days of chest drainage
\> 40ml/d, assessed during inhospital stay
Time frame: 2 years
Mortality rate
Inhospital or during follow-up, exclude the discharge from hospital against doctors' suggestions.
Time frame: 2 years
Level of coagulation indexes.
Blood samples were measured by coagulation function test during follow-up
Time frame: 2 years
Change in resting oxygen saturation
Answer question through telephone or other communication
Time frame: 2 years
Value of tricuspid annular plane systolic excursion
Measured by echocardiology from follow-up
Time frame: 2 years
Level of brain natriuretic peptide (BNP)
Measured during follow-up
Time frame: 2 years
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