Anticoagulation Medicine in Surgical Repair for Total Anomalous Pulmonary Venous Connection

  • STATUS
    Recruiting
  • End date
    Mar 1, 2022
  • participants needed
    150
  • sponsor
    Guangdong Provincial People's Hospital
Updated on 24 January 2021

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.

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.

Details
Condition Scimitar Syndrome
Treatment Anticoagulant Solutions, No anticoagulant solutions, Anticoagulant management
Clinical Study IdentifierNCT04241380
SponsorGuangdong Provincial People's Hospital
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

\. Infants and neonates who are diagnosed with TAPVC
\. Infants and neonates who undergo initial surgical repair for TAPVC

Exclusion Criteria

\. 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
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