Status:
TERMINATED
ZEPLAST- PED: ZEro_PLASma Trial in Small Infants Undergoing Cardiac Surgery
Lead Sponsor:
IRCCS Policlinico S. Donato
Conditions:
Bleeding
Cardiac Defect
Eligibility:
All Genders
1-2 years
Phase:
PHASE2
Brief Summary
In pediatric patients (newborns and infants weighing less than 10 kg) undergoing cardiac surgery with extracorporeal circulation postoperative bleeding represents a known complication with a significa...
Detailed Description
The study population will be randomized to two groups: ZEPLAST and control, respectively. The two groups will receive the same priming solution (containing Red Blood Cells and albumin 5%) and heparin...
Eligibility Criteria
Inclusion
- newborns and infants with weight lower than 10 kg undergoing cardiac surgery with extracorporeal circulation:
- informed consent signed by both parents or legal guardian.
Exclusion
- emergency surgery;
- known congenital coagulopathy or suspected based on anamnesis;
- participation to other clinical trials;
- known hypersensitivity to components and excipients of FFP , prothrombin complex concentrate or fibrinogen concentrate.
Key Trial Info
Start Date :
February 27 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04434001
Start Date
February 27 2020
End Date
June 30 2021
Last Update
November 3 2021
Active Locations (1)
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1
IRCCS Policlinico San Donato
San Donato Milanese, MI, Italy, 20097