Anticoagulation Medicine in Surgical Repair for Total Anomalous Pulmonary Venous Connection

Brief Title

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

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 Type

Interventional


Primary Outcome

Incidence of postoperative pulmonary venous obstruction (PVO)

Secondary Outcome

 Level of coagulation indexes.

Condition

Total Anomalous Pulmonary Venous Connection

Intervention

Anticoagulant Solutions

Study Arms / Comparison Groups

 Conventional treatment group
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

150

Start Date

February 20, 2020

Completion Date

March 1, 2022

Primary Completion Date

October 1, 2021

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.
      

Gender

All

Ages

N/A - 1 Year

Accepts Healthy Volunteers

No

Contacts

Jian Zhuang, M.D., Ph D., 020-83827812, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04241380

Organization ID

2019050505


Responsible Party

Sponsor

Study Sponsor

Guangdong Provincial People's Hospital


Study Sponsor

Jian Zhuang, M.D., Ph D., Principal Investigator, Guangdong Provincial People's Hospital


Verification Date

January 2020