Total Anomalous Pulmonary Venous Connection
Conditions
Keywords
Total anomalous pulmonary venous connection (TAPVC), Anticoagulant management, Pulmonary venous obstruction (PVO), outcomes
Brief summary
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.
Detailed description
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.
Interventions
DRUGAnticoagulant Solutions
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.
OTHERNo anticoagulant solutions
They will receive non-coagulant or coagulant treatment according to clinical conditions.
DRUGAnticoagulant management
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.
Sponsors
Guangdong Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Infants and neonates who are diagnosed with TAPVC * 2\. Infants and neonates who undergo initial surgical repair for TAPVC
Exclusion criteria
* 1\. Concommitant diagnosis including functional single ventricular, double outlet right ventricle, tricuspid atresia, pulmonary atresia or transposition of the great arteries. * 2\. Older than 1-year-old.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of postoperative pulmonary venous obstruction (PVO) | 2 years | The postoperative PVO were diagnosed by echocardiography or computed tomography scan |
| Days of chest drainage | 2 years | \> 40ml/d, assessed during inhospital stay |
| Mortality rate | 2 years | Inhospital or during follow-up, exclude the discharge from hospital against doctors' suggestions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Level of coagulation indexes. | 2 years | Blood samples were measured by coagulation function test during follow-up |
| Level of brain natriuretic peptide (BNP) | 2 years | Measured during follow-up |
| Change in resting oxygen saturation | 2 years | Answer question through telephone or other communication |
| Value of tricuspid annular plane systolic excursion | 2 years | Measured by echocardiology from follow-up |
Countries
China
Contacts
Primary ContactRong Liufu, M.D.
Outcome results
None listed