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Blood Purification for the Treatment of Pathogen Associated Shock
Sponsor: ExThera Medical Corporation
Summary
This study is a multi-center, randomized controlled feasibility trial to evaluate the initial safety and efficacy of a novel extracorporeal blood purification (EBP) therapy in critically ill patients with pathogen associated shock across 15 U.S. sites. Adults (18 years old and older) admitted to the ICU with all of the following: • Pathogen associated shock defined as: * The need for vasopressors to maintain mean arterial pressure (MAP) ≥ 65 mmHg despite adequate fluid resuscitation * Presence of a pathogen detected in the bloodstream within 72 hours of screening using commercially available in-vitro diagnostic testing
Official title: Blood Purification for the Treatment of Critically Ill Patients With Pathogen Associated Shock: A Multicenter, Randomized Controlled Feasibility Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
15
Start Date
2024-04-19
Completion Date
2025-09-30
Last Updated
2025-08-14
Healthy Volunteers
No
Conditions
Interventions
Seraph-100 + State of the Art Care
Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) manufactured by ExThera Medical Corporation in Martinez, CA. The Seraph 100 filter has been designed and manufactured to reduce residual risks as much as possible to ensure safe usage. Literature search results concluded that heparin-coated medical devices are safe and decrease platelet adhesion without affecting the adsorption of major adhesive proteins. The efficacy, safety, and risk-benefit data of the studies suggest that Seraph 100 is also safe and potentially beneficial by reducing the rate of thrombosis, without its use entailing a risk for patients. The achieved results from the above-mentioned testing and studies support the performance and safety of Seraph 100 consistent with the intended use. ExThera Medical concludes that the known and potential benefits of Seraph 100, when used to treat patients with pathogen associated shock, outweigh the known and potential risks when used according to the intended use.
State of the Art Care
"State of the Art care"is defined as the treatment algorithms outlined in the Surviving Sepsis Campaign for the treatment of septic shock, available at https://www.sccm.org/SurvivingSepsisCampaign/Home
Locations (9)
George Washington University
Washington D.C., District of Columbia, United States
Southeast Georgia Health System, Inc.
Brunswick, Georgia, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Good Samaritan Hospital
Corvallis, Oregon, United States
Trinity Health Mid Atlantic-SMMC
Langhorne, Pennsylvania, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Methodist Hospital
San Antonio, Texas, United States
University of Texas Health Science Center at San Antonio (UT Health San Antonio)
San Antonio, Texas, United States