Status:
TERMINATED
Assessing the Hemostatic Efficacy of Pathogen Reduced Platelets in Children Undergoing Cardiopulmonary Bypass Surgery: A Pilot Clinical Trial
Lead Sponsor:
Weill Medical College of Cornell University
Conditions:
Cardiopulmonary Bypass Surgery
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE4
Brief Summary
This study is testing whether pathogen reduced platelets can control bleeding as well as non-pathogen reduced platelets (otherwise known as large volume delayed sampling).
Detailed Description
This is a pilot clinical trial to assess the post-operative bleeding in children who receive pathogen-reduced (PR) platelet transfusions versus standard (large volume delayed sampling - LVDS) platelet...
Eligibility Criteria
Inclusion
- Male or female 0 up to and including 18 years of age
- Undergoing elective cardiopulmonary bypass surgery
- Are planned to have a chest tube placed in the operating room prior to chest closure
Exclusion
- \>/=19 years of age
- Preterm infants (less than 38-week gestational age at time of surgery)
- On extracorporeal membrane oxygenation (ECMO) or ventricular assist device prior to surgery
- Family requests limitation of blood products (i.e. Jehovah's Witness)
- Congenital bleeding disorder
- Are planned to require ECMO post-op
- Previously enrolled in the study
Key Trial Info
Start Date :
July 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2023
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT05293106
Start Date
July 5 2022
End Date
September 27 2023
Last Update
August 20 2024
Active Locations (2)
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1
Morgan Stanley Children's Hospital at Columbia University
New York, New York, United States, 10032
2
Komansky Children's Hospital at Weill Cornell
New York, New York, United States, 10065