SeaStar Medical Reports Statistically Significant Survival Findings from Post-Approval QUELIMMUNE® SAVE Registry Analysis in Pediatric Sepsis-Associated AKI
SeaStar Medical presented late-breaking post-approval data at ASN Kidney Week showing QUELIMMUNE (SCD-PED)-treated pediatric patients with sepsis-associated AKI had 65.1% Day 90 survival versus 47.4% in a KID comparator cohort (P=0.043), more than double the odds of survival (OR 2.07). Survival to hospital discharge was also significantly higher (P=0.04), all four mortality models favored treatment with a 34-40% reduction in mortality hazard, and no device-related adverse events were reported.
Key figures
- Drug Name
- QUELIMMUNE (SCD-PED)
- Phase Of Trial
- Post-approval SAVE registry (observational)
- Odds ratio
- 2.07
- Primary p value
- 0.043
- Device related aes
- 0
- Treatment cohort n
- 43
- Comparator cohort n
- 196
- Day90 survival treatment
- 65.1%
- Day90 survival comparator
- 47.4%
- Rrt independence among survivors
- 83% (20 of 24)
- Bayesian probability higher survival
- 98.2%
AI analysis
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