Abstract: FR-PO136
Safety Summary of the Selective Cytopheretic Device (SCD): A Review of Safety Data Across Multiple Clinical Trials in ICU Patients with AKI and Multi-Organ Failure
Session Information
- AKI: Outcomes, RRT
November 03, 2023 | Location: Exhibit Hall, Pennsylvania Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Acute Kidney Injury
- 102 AKI: Clinical, Outcomes, and Trials
Authors
- Catanzaro, David, SeaStar Medical, Denver, Colorado, United States
- Goldstein, Stuart, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, United States
- Yessayan, Lenar Tatios, University of Michigan, Ann Arbor, Michigan, United States
- Chung, Kevin K., SeaStar Medical, Denver, Colorado, United States
- Scribe, Emily, SeaStar Medical, Denver, Colorado, United States
- Humes, H. David, University of Michigan, Ann Arbor, Michigan, United States
Background
AKI is a frequent and serious complication in critically ill patients, occurring at a rate of 1 in 5 adults and 1 in 3 children hospitalized with acute illness. AKI requiring CKRT is a significant complication in ICU patients with mortality rates exceeding 50%. A dysregulated immune response can lead to systemic inflammation caused by a hyperactivity of pro-inflammatory neutrophils & monocytes leading to tissue damage. Damage resulting from hyperinflammation associated with AKI frequently progresses to other organs, such as the heart, lung, or liver. The SCD is an investigational medical device in a new class of cell-directed extracorporeal therapies distinct from cytokine adsorbers or filters, as it targets activated leukocytes, the key cellular sources driving the hyperinflammatory process. This report summarizes safety data from the major clinical studies of the SCD across a variety of patient types with AKI and multi-organ failure.
Methods
Safety was assessed in each study through the collection of AEs & SAEs. All-cause mortality was also assessed. As all-cause mortality can help in interpreting safety, this report will also summarize survival rates in each study.
Results
Results from each of the 5 studies will be described herein, including that 5 of 6 studies had no device-related SAEs and AEs from each study were consistent with those expected in a critically-ill ICU population. Although studies were not powered to detect differences in mortality, there were trends toward higher survival rates in SCD patients vs. controls.
Conclusion
These studies support that the SCD can be added as a therapeutic intervention in critically ill AKI patient populations with additional multi-organ failure without adding additional safety risks. Any intervention with the potential to improve survival in such a critical patient population would be welcome.
Summary of Adverse Events from Studies
| Study (Descriptor) | # AEs | # SAEs |
| Study 1 (China Pilot Study) | 14 | 0 |
| Study 2 (ARF-002) | 199 | 28 |
| Study 3 (SCD-003) | 354 | 80 |
| Study 4 (SCD-PED-01) | 47 | 12 |
| Study 5 (SCD-005) | 70 | 50 |
| Totals | 684 | 170 |
Funding
- Commercial Support – SeaStar Medical