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Anticoagulation Medicine in Surgical Repair for Total Anomalous Pulmonary Venous Connection

Primary Purpose

Total Anomalous Pulmonary Venous Connection

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Anticoagulant Solutions
No anticoagulant solutions
Anticoagulant management
Sponsored by
Guangdong Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Total Anomalous Pulmonary Venous Connection focused on measuring Total anomalous pulmonary venous connection (TAPVC), Anticoagulant management, Pulmonary venous obstruction (PVO), outcomes

Eligibility Criteria

undefined - 1 Year (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Guangdong Provincial People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional treatment group

Anti-coagulant treatment

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 17, 2020
Last Updated
February 17, 2020
Sponsor
Guangdong Provincial People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04241380
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 20, 2020 (Anticipated)
Primary Completion Date
October 1, 2021 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangdong Provincial People's Hospital

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Total Anomalous Pulmonary Venous Connection
Keywords
Total anomalous pulmonary venous connection (TAPVC), Anticoagulant management, Pulmonary venous obstruction (PVO), outcomes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional treatment group
Arm Type
Active Comparator
Arm 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.
Arm Title
Anti-coagulant treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Anticoagulant Solutions
Other Intervention Name(s)
Continuous infusion heparin
Intervention Description
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
Other
Intervention Name(s)
No anticoagulant solutions
Intervention Description
They will receive non-coagulant or coagulant treatment according to clinical conditions.
Intervention Type
Drug
Intervention Name(s)
Anticoagulant management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of postoperative pulmonary venous obstruction (PVO)
Description
The postoperative PVO were diagnosed by echocardiography or computed tomography scan
Time Frame
2 years
Title
Days of chest drainage
Description
> 40ml/d, assessed during inhospital stay
Time Frame
2 years
Title
Mortality rate
Description
Inhospital or during follow-up, exclude the discharge from hospital against doctors' suggestions.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Level of coagulation indexes.
Description
Blood samples were measured by coagulation function test during follow-up
Time Frame
2 years
Title
Change in resting oxygen saturation
Description
Answer question through telephone or other communication
Time Frame
2 years
Title
Value of tricuspid annular plane systolic excursion
Description
Measured by echocardiology from follow-up
Time Frame
2 years
Title
Level of brain natriuretic peptide (BNP)
Description
Measured during follow-up
Time Frame
2 years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rong Liufu, M.D.
Phone
020-83827812
Email
liufurong103@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Zhuang, M.D., Ph D.
Organizational Affiliation
Guangdong Provincial People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
520000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaobing Liu, M.D., Ph. D
Phone
15989201782
Email
liuxb21@aliyun.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Anticoagulation Medicine in Surgical Repair for Total Anomalous Pulmonary Venous Connection

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