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QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry
Sponsor: SeaStar Medical
Summary
QUELIMMUNE is FDA-approved under an HDE for the treatment of pediatric patients (weight ≥10kg and age ≤22 years) with AKI due to sepsis or a septic condition on antibiotic therapy and requiring RRT. The purpose of this surveillance registry is to prospectively collect safety data among all patients treated with QUELIMMUNE under the HDE. More specifically, we intend on comparing the incidence of new (secondary) blood stream infections in the first 28 days after SCD-PED initiation to a comparator group of matched CKRT patients with sepsis who did not receive treatment with QUELIMMUNE
Official title: Pediatric Selective Cytopheretic Device (SCD-PED, QUELIMMUNE) for Critically Ill Children With Acute Kidney Injury: A Humanitarian Device Exemption (HDE) Surveillance Registry Protocol
Key Details
Gender
All
Age Range
Any - 22 Years
Study Type
OBSERVATIONAL
Enrollment
300
Start Date
2024-07-19
Completion Date
2026-05
Last Updated
2026-03-23
Healthy Volunteers
No
Interventions
QUELIMMUNE (SCD-PED)
QUELIMMUNE device used as part of clinical practice.
Locations (15)
Children's of Alabama
Birmingham, Alabama, United States
Lucile Packard Children's Hospital Stanford
Palo Alto, California, United States
UCSF Benioff Children's
San Francisco, California, United States
HealthONE HCA Rocky Mountain Children's Hospital
Denver, Colorado, United States
Children's Hospital of Atlanta - Arthur M. Blank
Atlanta, Georgia, United States
Children's Hospital of Atlanta - Scottish Rite
Atlanta, Georgia, United States
Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
CS Mott Children's Hospital
Ann Arbor, Michigan, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Cleveland Clinic Children's Hospital
Cleveland, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Monroe Carrell Jr Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Children's Medical Center Dallas
Dallas, Texas, United States
Cook Children's Hospital
Fort Worth, Texas, United States
Texas Children's Hospital
Houston, Texas, United States