Anticoagulation Medicine in Surgical Repair for Total Anomalous Pulmonary Venous Connection

Not Applicable

• Conditions: Total Anomalous Pulmonary Venous Connection
• Interventions: Drug: Anticoagulant Solutions; Other: No anticoagulant solutions; Drug: Anticoagulant management

• Registration Number: NCT04241380
• Lead Sponsor: Guangdong Provincial People's Hospital

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.

Study Timeline

• Status Verified: 2020-01
• Study First Submitted: 2020-01-17
• Study First Submitted QC: 2020-01-23
• Study First Posted: 2020-01-27
• Last Update Submitted: 2020-02-17
• Last Update Posted: 2020-02-19
• Study Start: 2020-02-20
• Primary Completion: 2021-10-01
• Study Completion: 2022-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anti-coagulant treatment	Anticoagulant Solutions	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.
Conventional treatment group	Anticoagulant management	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.
Conventional treatment group	No anticoagulant solutions	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China