QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry

NCT ID: NCT06517810

Last Updated: 2025-10-24

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-19

Study Completion Date

2026-05-31

Brief Summary

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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

Detailed Description

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Conditions

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Acute Kidney Injury Acute Kidney Injury Due to Sepsis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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)

Intervention Type DEVICE

QUELIMMUNE device used as part of clinical practice.

Interventions

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QUELIMMUNE (SCD-PED)

QUELIMMUNE device used as part of clinical practice.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* All patients initiated on QUELIMMUNE therapy under the HDE-approved indication

Exclusion Criteria

* Weight \<10kg
* Age \>22 years
* Known allergy to any components of QUELIMMUNE
Maximum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SeaStar Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Children's of Alabama

Birmingham, Alabama, United States

Site Status RECRUITING

Lucile Packard Children's Hospital Stanford

Palo Alto, California, United States

Site Status RECRUITING

UCSF Benioff Children's

San Francisco, California, United States

Site Status RECRUITING

Children's Hospital of Atlanta - Arthur M. Blank

Atlanta, Georgia, United States

Site Status NOT_YET_RECRUITING

Children's Hospital of Atlanta - Scottish Rite

Atlanta, Georgia, United States

Site Status NOT_YET_RECRUITING

Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Site Status RECRUITING

CS Mott Children's Hospital

Ann Arbor, Michigan, United States

Site Status NOT_YET_RECRUITING

Cincinnati Children's Hospital

Cincinnati, Ohio, United States

Site Status RECRUITING

Cleveland Clinic Children's Hospital

Cleveland, Ohio, United States

Site Status NOT_YET_RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Children's Medical Center Dallas

Dallas, Texas, United States

Site Status RECRUITING

Cook Children's Hospital

Fort Worth, Texas, United States

Site Status RECRUITING

Texas Children's Hospital

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Mohamed Zidan, MD

Role: CONTACT

844-427-8100

Kevin K Chung, MD

Role: CONTACT

844-427-8100

Other Identifiers

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SCD-PED-HDE-1

Identifier Type: -

Identifier Source: org_study_id

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