QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry
SAVE
Pediatric Selective Cytopheretic Device (SCD-PED, QUELIMMUNE) for Critically Ill Children With Acute Kidney Injury: A Humanitarian Device Exemption (HDE) Surveillance Registry Protocol
1 other identifier
observational
300
1 country
15
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2024
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2024
CompletedStudy Start
First participant enrolled
July 19, 2024
CompletedFirst Posted
Study publicly available on registry
July 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedMarch 23, 2026
April 1, 2025
1.8 years
July 18, 2024
March 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety
New (secondary) bloodstream infections within 28 days from the time of QUELIMMUNE initiation or through hospital discharge, whichever is sooner
28 days or through hospital discharge, whichever is sooner
Study Arms (1)
QUELIMMUNE Surveillance Registry Participants
All patients treated with the QUELIMMUNE device as a part of clinical practice under the approved HDE indication must be included in this registry.
Interventions
QUELIMMUNE device used as part of clinical practice.
Eligibility Criteria
Pediatric patients (weight ≥10kg and age ≤22 years) with acute kidney injury (AKI) due to sepsis or a septic condition on antibiotic therapy and requiring renal replacement therapy (RRT), per device Instructions For Use. All patients who receive treatment with QUELIMMUNE as part of their therapy are included in this registry.
You may qualify if:
- All patients initiated on QUELIMMUNE therapy under the HDE-approved indication
You may not qualify if:
- Weight \<10kg
- Age \>22 years
- Known allergy to any components of QUELIMMUNE
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SeaStar Medicallead
Study Sites (15)
Children's of Alabama
Birmingham, Alabama, 35233, United States
Lucile Packard Children's Hospital Stanford
Palo Alto, California, 94304, United States
UCSF Benioff Children's
San Francisco, California, 94618, United States
HealthONE HCA Rocky Mountain Children's Hospital
Denver, Colorado, 80205, United States
Children's Hospital of Atlanta - Arthur M. Blank
Atlanta, Georgia, 30329, United States
Children's Hospital of Atlanta - Scottish Rite
Atlanta, Georgia, 30342, United States
Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
CS Mott Children's Hospital
Ann Arbor, Michigan, 48109, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
Cleveland Clinic Children's Hospital
Cleveland, Ohio, 44106, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Monroe Carrell Jr Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232, United States
Children's Medical Center Dallas
Dallas, Texas, 75235, United States
Cook Children's Hospital
Fort Worth, Texas, 76104, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 90 Days
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2024
First Posted
July 24, 2024
Study Start
July 19, 2024
Primary Completion
May 1, 2026
Study Completion
May 1, 2026
Last Updated
March 23, 2026
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share