CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 17 enrolled
Drug / intervention
Therapeutic plasma exchangeprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04057872
NCT04057872Phase 1Completed

PILOT STUDY in the Use of Therapeutic Plasma Exchange in Adult Patients With Severe Sepsis

Alberta Health Services, Calgary·interventional·Posted Aug 15, 2019·Updated Oct 3, 2025

In Brief

A Phase 1 clinical trial evaluating Therapeutic plasma exchange for Septic Shock. Completed, enrolled 17 participants across 2 sites.

Detailed Summary

The incidence of sepsis (severe infection) has increased over the last four decades. Severe sepsis and septic shock are among the leading causes of death for patients admitted to critical care units with mortality ranging from 20-70% depending on totality of organ dysfunction. Outside of antibiotics and good bedside care, little has changed in the management of this life-threatening problem. Therapeutic plasma exchange (TPE) involves the separation of plasma from whole blood. The removed plasma is 'exchanged or replaced' with either IV fluids, albumin, blood products or a combination thereof. The primary objective of this study is to evaluate the safety of the TPE intervention protocol within 24 hours of study criteria being met. TPE is now a well-established program at the South Health Campus for neuro-muscular disorders. Since starting in May 2018, the investigators have performed over 150 runs making the SHC ICU one of the most experienced centers in Canada.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSeptic Shock
CountriesCanada
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedAug 15, 2019
Enrollment StartOct 21, 2020
Primary CompletionDec 31, 2024
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 6.9 years ago

Interventions

Therapeutic plasma exchangeprocedure

The removed plasma is 'exchanged or replaced' with either IV fluids, albumin, and/or Fresh frozen plasma