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Ensaio clínico

QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry

NCT: NCT06517810 · RECRUITING

ID NCTNCT06517810
EstadoRECRUITING
Data de início2024-07-19
SponsorSeaStar Medical (INDUSTRY)
First posted
Last updated

Resumo breve

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

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