Anticoagulation Medicine in Surgical Repair for Total Anomalous Pulmonary Venous Connection

Anticoagulation Medicine in Surgical Repair for Total Anomalous Pulmonary Venous Connection: a Randomize Multi-centers Study

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.

Study Overview

• Status: Unknown
• Conditions: Total Anomalous Pulmonary Venous Connection
• Intervention / Treatment: Other: No anticoagulant solutions; Drug: Anticoagulant management; Drug: Anticoagulant Solutions

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
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 520000
      • Recruiting
      • Guangdong Provincial People's Hospital
      • Contact: Xiaobing Liu, M.D., Ph. D; Phone Number: 15989201782; Email: liuxb21@aliyun.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: No anticoagulant solutions; They will receive non-coagulant or coagulant treatment according to clinical conditions.; Drug: 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.
Experimental: 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.	Drug: 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.; Other Names: Continuous infusion heparin

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of coagulation indexes.	Blood samples were measured by coagulation function test during follow-up	2 years
Change in resting oxygen saturation	Answer question through telephone or other communication	2 years
Value of tricuspid annular plane systolic excursion	Measured by echocardiology from follow-up	2 years
Level of brain natriuretic peptide (BNP)	Measured during follow-up	2 years

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Investigators: Principal Investigator: Jian Zhuang, M.D., Ph D., Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): February 20, 2020
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: January 17, 2020
• First Submitted That Met QC Criteria: January 23, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): February 19, 2020
• Last Update Submitted That Met QC Criteria: February 17, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: outcomes; Total anomalous pulmonary venous connection (TAPVC); Anticoagulant management; Pulmonary venous obstruction (PVO)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Vascular Malformations; Respiratory System Abnormalities; Scimitar Syndrome; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Heparin; Pharmaceutical Solutions; Anticoagulants
• Other Study ID Numbers: 2019050505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No