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ACTIVE NOT RECRUITING
NCT05011656
NA

Blood Purification for the Treatment of Pathogen Associated Shock

Sponsor: ExThera Medical Corporation

View on ClinicalTrials.gov

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

DEVICE

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.

DEVICE

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