Anticoagulation Medicine in Surgical Repair for Total Anomalous Pulmonary Venous Connection

NCT ID: NCT04241380

Last Updated: 2020-02-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-20
• Study Completion Date: 2022-03-01

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.

Conditions

Total Anomalous Pulmonary Venous Connection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional treatment group

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.

Group Type: ACTIVE_COMPARATOR

No anticoagulant solutions

Intervention Type: OTHER

They will receive non-coagulant or coagulant treatment according to clinical conditions.

Anticoagulant management

Intervention Type: DRUG

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.

Anti-coagulant treatment

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.

Group Type: EXPERIMENTAL

Anticoagulant Solutions

Intervention Type: DRUG

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.

Interventions

Anticoagulant 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.

Intervention Type: DRUG

No anticoagulant solutions

They will receive non-coagulant or coagulant treatment according to clinical conditions.

Intervention Type: OTHER

Anticoagulant 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.

Intervention Type: DRUG

Other Intervention Names

Continuous infusion heparin

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.

• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jian Zhuang, M.D., Ph D.

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial People's Hospital

Locations

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Rong Liufu, M.D.

Role: CONTACT

liufurong103@163.com

020-83827812

Facility Contacts

Xiaobing Liu, M.D., Ph. D

Role: primary

liuxb21@aliyun.com

15989201782

Other Identifiers

2019050505

Identifier Type: -

Identifier Source: org_study_id