Status:
COMPLETED
High-exchange ULTrafiltration to Enhance Recovery After Pediatric Cardiac Surgery
Lead Sponsor:
IWK Health Centre
Conditions:
Congenital Heart Disease
Eligibility:
All Genders
Phase:
NA
Brief Summary
Malformations of the heart are common; 1.35 million infants are born each year with congenital heart disease. Many of these defects carry a considerable threat to the individual's quality of life as w...
Eligibility Criteria
Inclusion
- Congenital heart patients (2.5 - 15kg) have consented for a planned cardiac surgery procedure requiring cardiopulmonary bypass.
- Parent or legal substitute decision-maker informed written consent to participate in the study.
Exclusion
- Patient or family refusal to participate.
- Patient over 15kg (Fontan or Glenn patients will be considered up to 18kg)
- No planned use of cardiopulmonary bypass
- Isolated ASD repair
- Known severe hematologic abnormality such as sick cell anemia, thalassemia, haemophilia A or B, von Willebrand disease or other.
- Known genetic syndrome with severe neurologic or multi-organ abnormalities and immune dysfunction such as DiGeorge Syndrome, Trisomy 18 or 13, Noonan syndrome. (Trisomy 21 may be included in the study).
- Known immunodeficiency syndrome or bone marrow pathology.
- Severe liver or renal disease.
Key Trial Info
Start Date :
September 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 21 2025
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT04920643
Start Date
September 28 2021
End Date
May 21 2025
Last Update
May 25 2025
Active Locations (1)
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1
IWK Health Centre
Halifax, Nova Scotia, Canada