Total Anomalous Pulmonary Venous ConnectionNCT04241380
Anticoagulation Medicine in Surgical Repair for Total Anomalous Pulmonary Venous Connection
A study testing Anticoagulant Solutions, No anticoagulant solutions and Anticoagulant management in people with Total Anomalous Pulmonary Venous Connection, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Total Anomalous Pulmonary Venous Connection
- What is being tested?
- Anticoagulant Solutions, No anticoagulant solutions and Anticoagulant management
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2020to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 year
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. Infants and neonates who are diagnosed with TAPVC
- 2. Infants and neonates who undergo initial surgical repair for TAPVC
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 520000
Xiaobing Liu, M.D., Ph. D, 15989201782, liuxb21@aliyun.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Anticoagulant Solutions, No anticoagulant solutions, Anticoagulant management
- Keywords
- Total anomalous pulmonary venous connection (TAPVC), Anticoagulant management, Pulmonary venous obstruction (PVO), outcomes
- Medical subject headings
- Scimitar Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticoagulant SolutionsDrug
Also called 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 5 mg/kg will be given every eight hours subsequently for 3 months.
No anticoagulant solutionsOther
They will receive non-coagulant or coagulant treatment according to clinical conditions.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: No anticoagulant solutions; Drug: 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. Receives: Drug: Anticoagulant Solutions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative pulmonary venous obstruction (PVO)
The postoperative PVO were diagnosed by echocardiography or computed tomography scan
Measured: 2 years
Days of chest drainage
> 40ml/d, assessed during inhospital stay
Measured: 2 years
Mortality rate
Inhospital or during follow-up, exclude the discharge from hospital against doctors' suggestions.
Measured: 2 years
Secondary outcomes (4)
Level of coagulation indexes.
Blood samples were measured by coagulation function test during follow-up
Measured: 2 years
Change in resting oxygen saturation
Answer question through telephone or other communication
Measured: 2 years
Value of tricuspid annular plane systolic excursion
Measured by echocardiology from follow-up
Measured: 2 years
Level of brain natriuretic peptide (BNP)
Measured during follow-up
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start20 Feb 2020 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Anomalous Pulmonary Venous ConnectionStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Zhuang, M.D., Ph D., Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241380
- Sponsor's protocol ID
- 2019050505
- Status last verified
- Jan 2020
- First submitted
- 17 Jan 2020
- Last updated
- 19 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticoagulation Medicine in Surgical Repair for Total Anomalous Pulmonary Venous Connection: a Randomize Multi-centers Study
- ClinicalTrials.gov ID
- NCT04241380
- Acronym / sponsor ID
- 2019050505
- Keywords
- Total anomalous pulmonary venous connection (TAPVC), Anticoagulant management, Pulmonary venous obstruction (PVO), outcomes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 20 Feb 2020 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 27 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional treatment group | Active comparator | Other: No anticoagulant solutions, Drug: Anticoagulant managementPatients 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. |
| Anti-coagulant treatment | Experimental | Drug: Anticoagulant SolutionsContinuous 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. |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 1. Infants and neonates who are diagnosed with TAPVC
- 2. Infants and neonates who undergo initial surgical repair for TAPVC
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anticoagulant SolutionsAlso: Continuous infusion heparinPatients 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. | Drug | Anti-coagulant treatment |
| No anticoagulant solutionsThey will receive non-coagulant or coagulant treatment according to clinical conditions. | Other | Conventional treatment group |
| Anticoagulant managementContinuous 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. | Drug | Conventional treatment group |
Primary outcome
Incidence of postoperative pulmonary venous obstruction (PVO)
Time frame: 2 years
The postoperative PVO were diagnosed by echocardiography or computed tomography scan
Days of chest drainage
Time frame: 2 years
> 40ml/d, assessed during inhospital stay
Mortality rate
Time frame: 2 years
Inhospital or during follow-up, exclude the discharge from hospital against doctors' suggestions.
4 secondary outcomes
Level of coagulation indexes.
Time frame: 2 years
Change in resting oxygen saturation
Time frame: 2 years
Value of tricuspid annular plane systolic excursion
Time frame: 2 years
Level of brain natriuretic peptide (BNP)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Total Anomalous Pulmonary Venous Connection
RecruitingObservational study
An Integrated Prenatal and Postnatal Treatment Model for the Treatment of Newborns With Critical Congenital Heart Disease
Congenital Heart Disease, Coarctation of Aorta
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian Zhuang, M.D., Ph D. principal investigator
Guangdong Provincial People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anticoagulant Solutions, No anticoagulant solutions and Anticoagulant management in people with Total Anomalous Pulmonary Venous Connection, run by Guangdong Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rong Liufu, M.D. (020-83827812, liufurong103@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative pulmonary venous obstruction (PVO) (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2020.