The SAVE Surveillance Registry is a Real-World Evidence (RWE) surveillance program that is designed to confirm safety and efficacy of the QUELIMMUNE therapy. Medical institutions employing the QUELIMMUNE therapy will continue to collect RWE for up to the first 300 patients treated with QUELIMMUNE. Specific outcomes data will include 90-day survival and dialysis dependency along with safety data with plans to compare to an existing control group of similar illness severity. SeaStar Medical believes that initial results from the SAVE Surveillance Registry will support broader adoption of the QUELIMMUNE therapy, inform payer discussions, and complement the company’s ongoing effort to recruit patients into its adult NEUTRALIZE-AKI pivotal trial.
Re the Interim ....Review board can curtail enrollment if the data they see shows very clear over whelming benefit . So if they are seeing 40% reduction in mortality and only 5 % needing dialysis after 90 days they could say " we want you to continue but you dont need to enroll the full 200 patients "
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