Assessing the Hemostatic Efficacy of Pathogen Reduced Platelets in Children Undergoing Cardiopulmonary Bypass Surgery: A Pilot Clinical Trial (PEDITREC)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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).
Full 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 transfusions both during and for 24 hours following cardiopulmonary bypass surgery.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 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 criteria
- >/=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
Trial design
Primary purpose
Allocation
Interventional model
Masking
9 participants in 3 patient groups
Trial contacts and locations
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Central trial contact
Brett Anderson, MD; Marianne Nellis, MD
Data sourced from clinicaltrials.gov
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