A New Multimodal and Semi-specific Therapeutic Plasmapheresis Concept, a Case Series Study (CFPP)

Centrifugation and Filtration Plasmapheresis (CFPP): a New Multimodal and Semi-specific Therapeutic Plasmapheresis Concept, a Case Series Study

Global demand for therapeutic plasmapheresis is rising to treat various immunological, rheological, and lipoprotein-related disorders. Traditional therapeutic plasma exchange (TPE) removes plasma entirely and replaces it with costly substitution fluids, making it less sustainable. Semi-specific methods like plasma adsorption and double-filtration plasmapheresis (DFPP) avoid this by purifying and reinfusing the patient's own plasma.

DFPP, although effective and widely reimbursed in Europe and Asia, relies on membrane-based plasma separation systems that require high blood flow rates and offer limited plasma extraction efficiency, which prolongs treatment and often necessitates central venous access.

Centrifugation-based systems allow lower blood flow rates and higher plasma extraction ratios, but existing devices are not designed for automated double-cascade plasmapheresis.

To address these limitations, our department has implemented a new strategy: Centrifugation and Filtration Plasmapheresis (CFPP), which combines centrifugation for initial plasma separation with membrane filtration for secondary purification. CFPP maintains the safety and efficacy of DFPP while offering key advantages: easier peripheral venous access, shorter procedures, no need for replacement fluids, and reinfusion of purified autologous plasma.

Study Overview

• Status: Completed
• Conditions: Plasmapheresis

Detailed Description

The global demand for specific and semi-specific therapeutic plasmapheresis is steadily increasing to address immunological disorders ("immunoapheresis"), rheological and microvascular disorders ("rheopheresis"), and lipoprotein disorders ("lipoprotein apheresis"). These procedures require plasma to be separated from the cellular components of blood. Once separated, plasma can either be entirely removed and replaced with a substitution fluid-referred to as therapeutic plasma exchange (TPE)-a non-specific apheresis method that is costly and unsustainable due to the use of valuable fluids such as fresh frozen plasma or human albumin; or it can be treated using semi-specific or specific methods.

This secondary treatment can involve adsorption columns (plasma adsorption) or semi-specific filtration membranes, known as double-filtration plasmapheresis (DFPP) or double-cascade plasmapheresis. DFPP is a safe, efficient, and multimodal semi-specific plasmapheresis technique that is reimbursed in Europe and Asia, but surprisingly not in the United States. It is performed using certified automated devices such as the Plasauto® (Asahi®) or the HF440® (Infomed®), which use membrane filtration for initial plasma separation. However, this approach requires high blood flow rates (at least 80 mL/min), making peripheral venous access challenging. Additionally, the plasma extraction ratio is limited to approximately 33%, thereby prolonging the procedure.

In contrast, centrifugation-based plasma separation enables lower blood flow rates (as low as 40 mL/min) and achieves higher plasma extraction ratios (up to 60%), facilitating the use of peripheral venous access and reducing procedure duration. Unfortunately, current certified centrifugation-based systems-such as the Optia® (Terumo®) and the Comtech® (Fresenius®)-are not designed for automated double-cascade plasmapheresis.

To overcome these limitations, our team in Metz has implemented a custom technical setup that combines initial plasma separation by centrifugation (using the Optia® system) with secondary plasma treatment via membrane filtration (using Cascadeflo-EC® or Rheofilter® from Asahi®). We have termed this approach Centrifugation and Filtration Plasmapheresis (CFPP). CFPP is as safe and effective as DFPP, while integrating the advantages of centrifugation (lower blood flow, reduced need for central venous access, shorter treatment time) with the benefits of double-cascade plasmapheresis (semi-specific plasma purification, no need for fluid replacement, and reinfusion of the patient's own purified plasma).

• Study Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• France
  • Metz, France, 57085
    • CHR Metz-Thionville Hopital de Mercy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

indication for plasmapheresis treatment

Description

Inclusion Criteria:

• Indication for plasmapheresis treatment

Exclusion Criteria:

• Refusal to allow the use of one's data in the study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients treated with CFPP in our department in 2025

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of the biological and clinical efficacy of the CFPP procedure	Qualitative outcome describing the biological and clinical efficacy of the CFPP procedure according to patient file data	3 months after CFPP initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Number and frequency of adverse events related to CFPP	3 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional Metz-Thionville
• Investigators: Principal Investigator: Benjamin SAVENKOFF, MD, CHR Metz-Thionville

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Actual): February 1, 2026
• Study Completion (Actual): February 1, 2026

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Plasmapheresis; case series; Centrifugation; double-filtration (DFPP)
• Other Study ID Numbers: 2026-02-Obs-CHRMT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: According to French law and the guidelines of the French Data Protection Authority (CNIL), individual participant data cannot be publicly shared. However, study findings will be disseminated through peer-reviewed publications and presentations at scientific conferences.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No