Blood Purification for the Treatment of Pathogen Associated Shock

NCT05011656 | Active Not Recruiting DMC FDA Device

• 1 other identifier: PURIFY Multi-center RCT
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 9

Brief 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

Conditions

Septic Shock

Keywords

pathogen associated shock

Outcome Measures

Primary Outcomes (2)

• Efficacy - ICU-free days in the first 28 days

  Alive and not in the ICU (for at least a fulle 24 hours) in the first 28 days from the time of randomization

  First 28 days

• Safety - Adverse Events

  SAEs and \>/= grade 3 AEs per CTCAE v5 evaluated from enrollment until the end of hospitalization

  Discharge from hospital

Secondary Outcomes (6)

• Mortality

  28 days

• Ventilator-free days in the first 28 days

  First 28 days

• Vasopressor-free days in the first 28 days

  First 28 days

• Kidney replacement therapy-free days in the first 28 days

  First 28 days

• Hospital Stay

  through study completion, an average of 90 days

Study Arms (2)

1- Seraph-100 plus State of the Art Care

EXPERIMENTAL

The Seraph 100 Filter is a single use, disposable column packed with ultra-high molecular weight polyethylene beads which have been modified to contain endpoint attached heparin on the surface. Seraph 100 is an extracorporeal broad-spectrum sorbent hemoperfusion device for reduction of pathogens from the bloodstream. It is intended for use with standard, commercially available bloodlines compatible with the pump system used. Female Luer connectors are required to connect to the Seraph 100 blood ports.

Device: Seraph-100 + State of the Art Care

2 - State of the Art Care

ACTIVE COMPARATOR

"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

Device: State of the Art Care

Interventions

Seraph-100 + State of the Art Care DEVICE

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.

1- Seraph-100 plus State of the Art Care

State of the Art Care DEVICE

"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

2 - State of the Art Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted to an ICU with pathogen associated shock defined as:
• The need for vasopressors to maintain mean arterial pressure (MAP) ≥ 65 mmHg despite adequate fluid resuscitation, AND
• Presence of a pathogen detected in the bloodstream within 72 hours of screening using commercially available in-vitro diagnostic testing
• Male or non-pregnant female adult
• At least 18 years of age at time of enrollment

You may not qualify if:

• Pregnant or breast feeding
• Anticipated transfer to another hospital (that is not a study site) within 72 hours for any reason
• Not anticipated to survive more than 24 hours
• Known allergy to heparin sodium
• Patients who cannot tolerate placement of double-lumen catheter
• High risk of bleeding (platelet count \<50mm3 or International Normalized Ratio (INR) \>2) unless adequate line for treatment already placed (e.g. ECMO or RRT/CRRT)
• Inability to tolerate extracorporeal therapy (defined as MAP\<65 despite fluids and vasopressors)
• Advanced cancer (defined as stage IV) with life expectancy of less than 30 days
• Unable to obtain informed consent from either patient or legally authorized representative (LAR)
• Hypotension and volume depletion due to etiologies other than sepsis.
• Neutropenia with an absolute neutrophil count \<500mm3
• Patients must be treated with one of the antimicrobial agents listed in the Antimicrobial Management Guideline (Table 19). Patients who require treatment with an antimicrobial outside of this list while still receiving treatment with the investigational device must be excluded from the study.
• If a patient enters the study and later requires a change in the antimicrobial agent used to one which is not listed in the Antimicrobial Management Guideline while still receiving treatment with the investigational device, that patient must be removed from this trial. Clinical data for any patient removed from the trial for this reason will continue to be collected for safety evaluation".
• Patient is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator or IRB/ethics committee.
• Advanced directive for "Do Not Resuscitate".

Sponsors & Collaborators

• ExThera Medical Corporation: lead
• Uniformed Services University of the Health Sciences: collaborator

Study Sites (9)

George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

Southeast Georgia Health System, Inc.

Brunswick, Georgia, 31520, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Good Samaritan Hospital

Corvallis, Oregon, 97330, United States

Location

Trinity Health Mid Atlantic-SMMC

Langhorne, Pennsylvania, 19047, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Methodist Hospital

San Antonio, Texas, 78229, United States

Location

University of Texas Health Science Center at San Antonio (UT Health San Antonio)

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Lakhmir Chawla, MD

  ExThera Medical

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Unblinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to receive either Arm 1: Seraph 100 treatment plus 'State of the Art' or Arm 2: 'State of the Art' care alone. "State of the Art care" will be 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

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 18, 2021
• Study Start: April 19, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)