Assessing the Hemostatic Efficacy of Pathogen Reduced Platelets in Children Undergoing Cardiopulmonary Bypass Surgery: A Pilot Clinical Trial
NCT ID: NCT05293106
Last Updated: 2024-08-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
9 participants
INTERVENTIONAL
2022-07-05
2023-09-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pathogen-reduced (PR) platelet transfusions
FDA approved and already used in this patient population
Platelet Transfusion
All platelet transfusions will be given as 10mL/kg as is considered standard of care.
Large volume delayed sampling - LVDS
FDA approved and already used in this patient population
Platelet Transfusion
All platelet transfusions will be given as 10mL/kg as is considered standard of care.
No platelet transfusion
Subject will not receive a platelet transfusion
No interventions assigned to this group
Interventions
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Platelet Transfusion
All platelet transfusions will be given as 10mL/kg as is considered standard of care.
Eligibility Criteria
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Inclusion Criteria
* Undergoing elective cardiopulmonary bypass surgery
* Are planned to have a chest tube placed in the operating room prior to chest closure
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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Marianne Nellis, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Locations
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Morgan Stanley Children's Hospital at Columbia University
New York, New York, United States
Komansky Children's Hospital at Weill Cornell
New York, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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21-11024115
Identifier Type: -
Identifier Source: org_study_id
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