NCT04241380

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
24 days until next milestone

Study Start

First participant enrolled

February 20, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

February 19, 2020

Status Verified

January 1, 2020

Enrollment Period

1.6 years

First QC Date

January 17, 2020

Last Update Submit

February 17, 2020

Conditions

Total Anomalous Pulmonary Venous Connection

Keywords

Total anomalous pulmonary venous connection (TAPVC)Anticoagulant managementPulmonary venous obstruction (PVO)outcomes

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Level of coagulation indexes.

    2 years

  • Change in resting oxygen saturation

    2 years

  • Value of tricuspid annular plane systolic excursion

    2 years

  • Level of brain natriuretic peptide (BNP)

    2 years

Study Arms (2)

Conventional treatment group

ACTIVE COMPARATOR

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 solutionsDrug: Anticoagulant management

Anti-coagulant treatment

EXPERIMENTAL

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

Interventions

Anticoagulant SolutionsDRUG

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.

Also known as: Continuous infusion heparin
Anti-coagulant treatment
No anticoagulant solutionsOTHER

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

Conventional treatment group
Anticoagulant managementDRUG

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.

Conventional treatment group

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \. Infants and neonates who are diagnosed with TAPVC
  • \. Infants and neonates who undergo initial surgical repair for TAPVC

You may not qualify if:

  • \. Concommitant diagnosis including functional single ventricular, double outlet right ventricle, tricuspid atresia, pulmonary atresia or transposition of the great arteries.
  • \. Older than 1-year-old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 520000, China

RECRUITING

MeSH Terms

Conditions

Scimitar Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiratory System AbnormalitiesVascular MalformationsCardiovascular AbnormalitiesCardiovascular DiseasesVascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Jian Zhuang, M.D., Ph D.

    Guangdong Provincial People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rong Liufu, M.D.

CONTACT

020-83827812liufurong103@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2020

First Posted

January 27, 2020

Study Start

February 20, 2020

Primary Completion

October 1, 2021

Study Completion

March 1, 2022

Last Updated

February 19, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)