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Anticoagulation Medicine in Surgical Repair for Total Anomalous Pulmonary Venous Connection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04241380
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
Guangdong Provincial People's Hospital

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.

Condition or disease Intervention/treatment Phase
Total Anomalous Pulmonary Venous Connection Drug: Anticoagulant Solutions Other: No anticoagulant solutions Drug: Anticoagulant management Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anticoagulation Medicine in Surgical Repair for Total Anomalous Pulmonary Venous Connection: a Randomize Multi-centers Study
Estimated Study Start Date : February 20, 2020
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

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 Name: Continuous infusion heparin




Primary Outcome Measures :
  1. Incidence of postoperative pulmonary venous obstruction (PVO) [ Time Frame: 2 years ]
    The postoperative PVO were diagnosed by echocardiography or computed tomography scan

  2. Days of chest drainage [ Time Frame: 2 years ]
    > 40ml/d, assessed during inhospital stay

  3. Mortality rate [ Time Frame: 2 years ]
    Inhospital or during follow-up, exclude the discharge from hospital against doctors' suggestions.


Secondary Outcome Measures :
  1. Level of coagulation indexes. [ Time Frame: 2 years ]
    Blood samples were measured by coagulation function test during follow-up

  2. Change in resting oxygen saturation [ Time Frame: 2 years ]
    Answer question through telephone or other communication

  3. Value of tricuspid annular plane systolic excursion [ Time Frame: 2 years ]
    Measured by echocardiology from follow-up

  4. Level of brain natriuretic peptide (BNP) [ Time Frame: 2 years ]
    Measured during follow-up



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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04241380


Contacts
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Contact: Rong Liufu, M.D. 020-83827812 liufurong103@163.com

Locations
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China, Guangdong
Guangdong Provincial People's Hospital Recruiting
Guangzhou, Guangdong, China, 520000
Contact: Xiaobing Liu, M.D., Ph. D    15989201782    liuxb21@aliyun.com   
Sponsors and Collaborators
Guangdong Provincial People's Hospital
Investigators
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Principal Investigator: Jian Zhuang, M.D., Ph D. Guangdong Provincial People's Hospital
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Responsible Party: Guangdong Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT04241380    
Other Study ID Numbers: 2019050505
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Guangdong Provincial People's Hospital:
Total anomalous pulmonary venous connection (TAPVC)
Anticoagulant management
Pulmonary venous obstruction (PVO)
outcomes
Additional relevant MeSH terms:
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Scimitar Syndrome
Lung Diseases
Respiratory Tract Diseases
Respiratory System Abnormalities
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases
Congenital Abnormalities
Heparin
Anticoagulants
Pharmaceutical Solutions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action