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임상시험

QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry

NCT: NCT06517810 · RECRUITING

NCT IDNCT06517810
상태RECRUITING
시작일2024-07-19
SponsorSeaStar Medical (INDUSTRY)
First posted
Last updated

간략 요약

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

공식 출처

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