Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2024-07-19
2026-05-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
QUELIMMUNE (SCD-PED)
QUELIMMUNE device used as part of clinical practice.
Interventions
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QUELIMMUNE (SCD-PED)
QUELIMMUNE device used as part of clinical practice.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Age \>22 years
* Known allergy to any components of QUELIMMUNE
22 Years
ALL
No
Sponsors
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SeaStar Medical
INDUSTRY
Responsible Party
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Locations
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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
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
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
Countries
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Central Contacts
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Other Identifiers
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SCD-PED-HDE-1
Identifier Type: -
Identifier Source: org_study_id
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