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Blood Purification

Seraph-100 + State of the Art Care for Septic Shock (PURIFY-RCT Trial)

N/A
Waitlist Available
Research Sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 90 days
Awards & highlights

PURIFY-RCT Trial Summary

This trial is to test a new extracorporeal blood purification (EBP) therapy to see if it is safe and effective in critically ill patients with pathogen associated shock.

Eligible Conditions
  • Septic Shock

PURIFY-RCT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 90 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy - ICU-free days in the first 28 days
Safety - Adverse Events
Secondary outcome measures
Hospital Stay
Kidney replacement therapy-free days in the first 28 days
Mortality
+3 more

PURIFY-RCT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 1- Seraph-100 plus State of the Art CareExperimental Treatment1 Intervention
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.
Group II: 2 - State of the Art CareActive Control1 Intervention
"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

Find a Location

Who is running the clinical trial?

Henry M. Jackson Foundation for the Advancement of Military MedicineLead Sponsor
92 Previous Clinical Trials
92,874 Total Patients Enrolled
Uniformed Services University of the Health SciencesFED
116 Previous Clinical Trials
91,553 Total Patients Enrolled
ExThera Medical CorporationIndustry Sponsor
4 Previous Clinical Trials
389 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What objective is this medical trial attempting to attain?

"The primary goal of this trial is to evaluate the efficacy of ICU-free days in the first 28 days after hospital discharge. Secondary outcomes being tracked include mortality measured both at admission and post-treatment, ventilator free days within the same period, and kidney replacement therapy free days for a minimum 72 hour duration."

Answered by AI

Are there any openings for volunteers to participate in this research?

"As per clinicaltrials.gov, this medical trial is not currently accepting new participants. Initially posted on December 15th 2021 and last updated April 1st 2022, it does not appear to be recruiting at present; however there are 165 other studies open for enrolment right now."

Answered by AI
~4 spots leftby Apr 2025