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Plasma Exchange

Plasma Exchange for Septic Shock (PLEXSIS Trial)

Phase 2
Recruiting
Led By Emily Rimmer, MD, MSc
Research Sponsored by University of Manitoba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
No Placebo-Only Group

Summary

"This trial will compare therapeutic plasma exchange to standard treatment in patients with septic shock at multiple hospitals to see if it is feasible."

Who is the study for?
This trial is for adults over 18 with septic shock, who have low blood pressure despite high-dose vasopressors and fluids, kidney injury as per KDIGO guidelines, need mechanical breathing support or have a low P/F ratio, significant drop in platelets, or severe acidosis with high lactate levels.
What is being tested?
The study tests if therapeutic plasma exchange can help patients with septic shock compared to standard treatments. Participants are randomly chosen to receive either the plasma exchange procedure or continue with their usual care without it.
What are the potential side effects?
Potential side effects of therapeutic plasma exchange may include allergic reactions, bleeding due to anticoagulants used during the procedure, infection at catheter insertion site, and changes in blood pressure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Assess the feasibility of a large, multicenter trial of TPE in patients with septic shock
Secondary study objectives
Assess the rate of enrollment and adherence to the protocol of those enrolled
Further understand the biological impact of TPE in sepsis
Number of participants that develop adverse reactions to TPE
Other study objectives
Mortality
Organ failure

Side effects data

From 2020 Phase 2 trial • 20 Patients • NCT04374149
10%
myocardial infarction
100%
80%
60%
40%
20%
0%
Study treatment Arm
1 - TPE Alone
2 - TPE Plus Ruxolitinib

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment ArmExperimental Treatment1 Intervention
Participants randomized to the Treatment Arm will received 1.0 plasma exchanges daily until discontinuation of vasopressors, death or to a maximum of 5 daily treatments. Solvent detergent plasma (SDP) or frozen plasma (FP) depending on availability will be used as the replacement fluid.
Group II: Standard of Care ArmActive Control1 Intervention
Participants randomized to the Control Arm will receive standard of care for the treatment of septic shock in accordance with local practice and informed by national and international guidelines.

Find a Location

Who is running the clinical trial?

University of TorontoOTHER
719 Previous Clinical Trials
1,042,472 Total Patients Enrolled
3 Trials studying Sepsis
1,190 Patients Enrolled for Sepsis
Health Sciences Centre Foundation, ManitobaOTHER
15 Previous Clinical Trials
9,253 Total Patients Enrolled
McMaster UniversityOTHER
916 Previous Clinical Trials
2,615,148 Total Patients Enrolled
5 Trials studying Sepsis
2,837 Patients Enrolled for Sepsis
~36 spots leftby Mar 2026
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