Anticoagulation Medicine in Surgical Repair for Total Anomalous Pulmonary Venous Connection

Study Overview
=================
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.

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

Conditions
-----------------
Total Anomalous Pulmonary Venous Connection

Intervention / Treatment
-----------------
* Drug: Anticoagulant Solutions
* Other: No anticoagulant solutions
* Drug: Anticoagulant management


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Maximum Age: 1 Year

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional treatment group<br>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. | Other: No anticoagulant solutions<br>* They will receive non-coagulant or coagulant treatment according to clinical conditions.<br>Drug: Anticoagulant management<br>* 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.<br>|
| Experimental: Anti-coagulant treatment<br>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. | Drug: Anticoagulant Solutions<br>* 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.<br>* Other names: Continuous infusion heparin;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative pulmonary venous obstruction (PVO) | The postoperative PVO were diagnosed by echocardiography or computed tomography scan | 2 years | 
| Days of chest drainage | > 40ml/d, assessed during inhospital stay | 2 years | 
| Mortality rate | Inhospital or during follow-up, exclude the discharge from hospital against doctors' suggestions. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of coagulation indexes. | Blood samples were measured by coagulation function test during follow-up | 2 years | 
| Change in resting oxygen saturation | Answer question through telephone or other communication | 2 years | 
| Value of tricuspid annular plane systolic excursion | Measured by echocardiology from follow-up | 2 years | 
| Level of brain natriuretic peptide (BNP) | Measured during follow-up | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total anomalous pulmonary venous connection (TAPVC), Anticoagulant management, Pulmonary venous obstruction (PVO), outcomes