Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06517810
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
QUELIMMUNE SCD-PED PediAtric SurVeillance REgistry
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pediatric Selective Cytopheretic Device SCD-PED QUELIMMUNE for Critically Ill Children With Acute Kidney Injury A Humanitarian Device Exemption HDE Surveillance Registry Protocol
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAVE
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
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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None