Anticoagulation Medicine in Surgical Repair for Total Anomalous Pulmonary Venous Connection
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|ClinicalTrials.gov Identifier: NCT04241380|
Recruitment Status : Recruiting
First Posted : January 27, 2020
Last Update Posted : February 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Total Anomalous Pulmonary Venous Connection||Drug: Anticoagulant Solutions Other: No anticoagulant solutions Drug: Anticoagulant management||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- Level of coagulation indexes. [ Time Frame: 2 years ]Blood samples were measured by coagulation function test during follow-up
- Change in resting oxygen saturation [ Time Frame: 2 years ]Answer question through telephone or other communication
- Value of tricuspid annular plane systolic excursion [ Time Frame: 2 years ]Measured by echocardiology from follow-up
- Level of brain natriuretic peptide (BNP) [ Time Frame: 2 years ]Measured during follow-up
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
|Contact: Rong Liufu, M.D.||firstname.lastname@example.org|
|Guangdong Provincial People's Hospital||Recruiting|
|Guangzhou, Guangdong, China, 520000|
|Contact: Xiaobing Liu, M.D., Ph. D 15989201782 email@example.com|
|Principal Investigator:||Jian Zhuang, M.D., Ph D.||Guangdong Provincial People's Hospital|