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Blood Purification for the Treatment of Pathogen Associated Shock (PURIFY-RCT)

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ClinicalTrials.gov Identifier: NCT05011656
Recruitment Status : Not yet recruiting
First Posted : August 18, 2021
Last Update Posted : August 24, 2021
Sponsor:
Collaborators:
Uniformed Services University of the Health Sciences
ExThera Medical Corporation
Information provided by (Responsible Party):
Henry M. Jackson Foundation for the Advancement of Military Medicine

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

Condition or disease Intervention/treatment Phase
Septic Shock Device: Seraph-100 + State of the Art Care Device: State of the Art Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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
Masking: None (Open Label)
Masking Description: Unblinded
Primary Purpose: Treatment
Official Title: Blood Purification for the Treatment of Critically Ill Patients With Pathogen Associated Shock: A Multicenter, Randomized Controlled Feasibility Trial
Estimated Study Start Date : September 1, 2021
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: 1- Seraph-100 plus State of the Art Care
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
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.

Active Comparator: 2 - 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
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




Primary Outcome Measures :
  1. Efficacy - ICU-free days in the first 28 days [ Time Frame: 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

  2. Safety - Adverse Events [ Time Frame: Discharge from hospital ]
    SAEs and >/= grade 3 AEs per CTCAE v5 evaluated from enrollment until the end of hospitalization


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 28 days ]
    Evaluate in-hospital mortality and mortality at 28 days

  2. Ventilator-free days in the first 28 days [ Time Frame: First 28 days ]
    Alive and free of mechanical ventilation (for at least a full 24 hours) in the first 28 days from the time of randomization

  3. Vasopressor-free days in the first 28 days [ Time Frame: First 28 days ]
    Alive and vasopressor-free for at least a 24-hour period in the first 28 days from the time of randomization

  4. Kidney replacement therapy-free days in the first 28 days [ Time Frame: First 28 days ]
    Alive and not on kidney replacement therapy for at least 72 hours.

  5. Hospital Stay [ Time Frame: through study completion, an average of 90 days ]
    number of days that the subject is hospitalized

  6. Survival [ Time Frame: through study completion, an average of 90 days ]
    Alive or dead 90 days after enrollment (if discharged from the hospital prior to 90 days after enrollment)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Admitted to an intensive care unit (ICU) with 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
  2. Male or non-pregnant female adult.
  3. At least 18 years of age at time of enrollment.
  4. Within 72 hours of admission to the ICU.

Exclusion Criteria:

  1. Pregnant or breast feeding.
  2. Anticipated transfer to another hospital (that is not a study site) within 72 hours for any reason.
  3. Not anticipated to survive more than 24 hours.
  4. Allergy to heparin sodium.
  5. Patients who cannot tolerate placement of double-lumen catheter.
  6. High risk of bleeding (platelet count <50mm3 or International normalized ratio >1.5).
  7. Inability to tolerate extra-corporeal therapy (defined as MAP<65 despite fluids and vasopressors).
  8. Advanced cancer (defined as stage IV).
  9. Unable to obtain informed consent from either patient or legally authorized representative.
  10. Hypotension and volume depletion due to etiologies other than sepsis.
  11. Neutropenia with an absolute neutrophil count <500mm3.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05011656


Contacts
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Contact: Marianne Spevak, BSHS 2406942067 mspevak@hjf.org
Contact: Catherine Grill, BSN 919-452-0288 cgrill@traumainsight.com

Sponsors and Collaborators
Henry M. Jackson Foundation for the Advancement of Military Medicine
Uniformed Services University of the Health Sciences
ExThera Medical Corporation
Investigators
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Study Chair: Kevin Chung, MD Uniformed Services University of the Health Sciences
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Responsible Party: Henry M. Jackson Foundation for the Advancement of Military Medicine
ClinicalTrials.gov Identifier: NCT05011656    
Other Study ID Numbers: PURIFY Multi-center RCT
First Posted: August 18, 2021    Key Record Dates
Last Update Posted: August 24, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Following completion of the study, results of this research will be in a scientific journal. Data will be available immediately following publication, with no end date, with data sharing at the discretion of the sponsor.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Henry M. Jackson Foundation for the Advancement of Military Medicine:
pathogen associated shock
Additional relevant MeSH terms:
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Shock
Pathologic Processes