PlasmapheresisCFPPNCT07515404
A New Multimodal and Semi-specific Therapeutic Plasmapheresis Concept, a Case Series Study
An observational study of Plasmapheresis, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plasmapheresis
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2026to 1 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: indication for plasmapheresis treatment
Who may be able to join
- Indication for plasmapheresis treatment
Who cannot join
- Refusal to allow the use of one's data in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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).
- Conditions
- Plasmapheresis
- Keywords
- Plasmapheresis, double-filtration (DFPP), Centrifugation, case series
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients treated with CFPP in our department in 2025 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months after CFPP initiation
Secondary outcomes (1)
Adverse events
Number and frequency of adverse events related to CFPP
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Jan 2026
- Primary completion1 Feb 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PlasmapheresisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin SAVENKOFF, MD, Principal investigator, CHR Metz-Thionville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515404
- Sponsor's protocol ID
- 2026-02-Obs-CHRMT
- Acronym
- CFPP
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Centrifugation and Filtration Plasmapheresis (CFPP): a New Multimodal and Semi-specific Therapeutic Plasmapheresis Concept, a Case Series Study
- ClinicalTrials.gov ID
- NCT07515404
- Acronym / sponsor ID
- CFPP / 2026-02-Obs-CHRMT
- Conditions
- Plasmapheresis
- Keywords
- Plasmapheresis, double-filtration (DFPP), Centrifugation, case series
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients treated with CFPP in our department in 2025 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- indication for plasmapheresis treatment
Key inclusion criteria (1 listed)
- Indication for plasmapheresis treatment
Key exclusion criteria (1 listed)
- Refusal to allow the use of one's data in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Description of the biological and clinical efficacy of the CFPP procedure
Time frame: 3 months after CFPP initiation
Qualitative outcome describing the biological and clinical efficacy of the CFPP procedure according to patient file data
1 secondary outcome
Adverse events
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin SAVENKOFF, MD principal investigator
CHR Metz-Thionville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plasmapheresis, run by Centre Hospitalier Régional Metz-Thionville at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the biological and clinical efficacy of the CFPP procedure (time frame: 3 months after CFPP initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.