Clinical trial NCT04241380: Anticoagulation Medicine in Surgical Repair for Total Anomalous Pulmonary Venous Connection
Official title: Anticoagulation Medicine in Surgical Repair for Total Anomalous Pulmonary Venous Connection: a Randomize Multi-centers Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Total Anomalous Pulmonary Venous Connection
Keywords: Total anomalous pulmonary venous connection (TAPVC)
Anticoagulant management
Pulmonary venous obstruction (PVO)
outcomes
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 150
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence of postoperative pulmonary venous obstruction (PVO)
timeFrame: 2 years
measure: Days of chest drainage
timeFrame: 2 years
measure: Mortality rate
timeFrame: 2 years
Secondary outcomes:
measure: Level of coagulation indexes.
timeFrame: 2 years
measure: Change in resting oxygen saturation
timeFrame: 2 years
measure: Value of tricuspid annular plane systolic excursion
timeFrame: 2 years
measure: Level of brain natriuretic peptide (BNP)
timeFrame: 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Jian Zhuang, M.D., Ph D.
role: PRINCIPAL_INVESTIGATOR
References: