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Exploration and research on the optimal anticoagulation strategy during cardiopulmonary bypass in neonates with congenital heart disease

Exploration and research on the optimal anticoagulation strategy during cardiopulmonary bypass in neonates with congenital heart disease

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069157
Enrollment
Unknown
Registered
2023-03-08
Start date
2023-02-14
Completion date
Unknown
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

neonatal congenital heart disease

Interventions

Pre-experimental control group:Injected heparin dose is 400U/kg
Pre-experimental high-dose group 1:Injected heparin dose is 500U/kg
Pre-experimental high-dose group 2:Injected heparin dose is 600U/kg
control group:Injected heparin dose is 400U/kg
optimal dose group:Optimum Heparin Dose in Pre-injection Experiment

Sponsors

Fuwai Hospital, National Center for Cardiovascular Diseases
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 0.1 Years

Inclusion criteria

Inclusion criteria: 1. Neonates with congenital heart disease =28 days old; 2. American Society of Anesthesiologists (ASA) rating: I-?; 3. Sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Newborns with congenital heart disease suffering from coagulation dysfunction before operation; 2. Neonates with congenital heart disease combined with severe liver and kidney dysfunction or neurological diseases before operation; 3. Extracorporeal life support is required before surgery; 4. Unknown preoperative blood type or lack of coagulation-related examinations; 5. Intraoperative extracorporeal circulation time > 3 hours, or operation time > 5 hours; 6. Has participated in other clinical research projects.

Design outcomes

Primary

MeasureTime frame
prothrombin fragment F1+2;

Secondary

MeasureTime frame
Thoracic drainage 24 hours after surgery;Usage of blood products 24 hours after surgery;Blood clotting index eight;Coagulation factor;Activated Clotting Time of WholeBlood;

Countries

China

Contacts

Public ContactLiu Jingping
liujinping@fuwai.com13601293946

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026