Therapeutic Plasma ExchangeNCT06652516
Comparison Between Centrifugation Based and Membrane Based Plasma Exchange
A study testing plasma exchange in people with Therapeutic Plasma Exchange, run by Alexandria University at 1 site in Egypt.
Trial summary
This study aims at comparing centrifugation based therapeutic plasma exchange (cTPE) versus membrane based therapeutic plasma exchange (mTPE) as regards performance, effectiveness and adverse events in patients indicated for TPE. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Therapeutic Plasma Exchange
- What is being tested?
- plasma exchange
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2023to 8 Dec 2023
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged more than 18 years old having indication for plasma exchange (based on American Society for Apheresis (ASFA) therapeutic category 1, 2, 3).
- Category I: includes disorders for which TPE is accepted as first-line therapy, either as primary stand-alone treatment or in conjunction with other modes of treatment. Examples include Guillain-Barre syndrome, acquired thrombotic thrombocytopenic purpura, and erythrocytapheresis in sickle cell diseases with certain complications (eg, stroke).
- Category II: includes disorders for which TPE is accepted as second-line therapy, either as a stand-alone treatment or in conjunction with other modes of treatment. Examples include life-threatening hemolytic anemia for cold agglutinin disease or Lambert-Eaton myasthenic syndrome.
- Category III: includes disorders for which the optimum role of apheresis therapy is not established. Decision making should be individualized. Examples include TPE for hyper-triglyceridemic pancreatitis or extracorporeal photopheresis for nephrogenic systemic fibrosis.
- Approval to sign a written consent.
Who cannot join
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Centrifugal Therapeutic Plasma Exchange and Membrane Therapeutic Plasma Exchange; a Comparative Study
This study aims at comparing centrifugation based therapeutic plasma exchange (cTPE) versus membrane based therapeutic plasma exchange (mTPE) as regards performance, effectiveness and adverse events in patients indicated for TPE.
Read the detailed description
- Study setting: Patients of this study were recruited from the hemodialysis unit of Alexandria Main University Hospital.
- Study design: Randomized prospective crossover study.
- Study population: Twenty patients having clinical indication for TPE.
- They were divided into 2 groups by 1 to 1 randomization Group A: ten patients received the first session of TPE by cTPE and the second session was performed by mTPE 48 hours later.
Group B: ten patients received the first session of TPE by mTPE and the second session was performed by cTPE 48 hours later.
Only the results of 2 sessions for each group were recorded in the study, even if the patients needed further sessions of TPE.
- Conditions
- Therapeutic Plasma Exchange
- Being tested
- plasma exchange
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plasma exchangeProcedure or surgery
comparison between the 2 methods of plasma exchange as regards efficacy, performance and adverse events.
Procedure of therapeutic plasma exchange (TPE) :
mTPE will be done by bellco hemodialysis machine (Formula 2000), while cTPE will be done by Nigale Plasma Collector (XJC 2000). The vascular access used for both types of plasma exchange will be central venous catheter inserted into the internal jugular vein, subclavian or femoral vein.
Prescription of TPE The amount of plasma to be treated is usually equivalent to the patient's estimated plasma volume (EPV).
Estimated plasma volume will be calculated using the following formula (Kaplan formula) in litres:
- EPV = 0.07 x wt (kg) x (1 - hematocrit) in males.
- EPV = 0.065 x wt (kg) x (1 - hematocrit) in females.
| Study group | Role | What they receive |
|---|---|---|
| cTPE | Active comparator | This group performed the first session of plasma exchange by centrifugation and the second session by membrane filtration Receives: Procedure: plasma exchange |
| mTPE | Active comparator | This group performed the first session of plasma exchange by membrane filtration and the second session by centrifugation Receives: Procedure: plasma exchange |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to setup and prime the machine (in minutes)
Measured: immediately after plasma exchange procedure
Procedure time (in minutes).
Measured: immediately after plasma exchange procedure
Time to exchange 1 litre of plasma (in minutes).
Measured: immediately after plasma exchange procedure
Blood flow rate (ml/minutes)
Measured: immediately after plasma exchange procedure
Plasma removal efficiency (PRE).
Plasma removal efficiency is an established metric used to analyse the performance of an apheresis device during a TPE procedure. It represents the fraction of plasma that has been removed in a TPE procedure in relation to the plasma that has been processed.
Measured: immediately after plasma exchange procedure
Efficacy in clearance of interleukin 6 and tumor necrosis factor alpha
serum level of interleukin 6 and tumor necrosis factor apha were assessed before and after each session of therapeutic plasma exchange
Measured: immediately after plasma exchange procedure
Adverse events
All adverse events occurring during the session were reported including any of the following
- Hemolysis.
- Urticaria.
- Hypotension.
- Hypocalcemia.
- Clotting of the extracorporeal circuit.
- Others.
Measured: immediately after plasma exchange procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start5 Jan 2023
- Primary completion10 Sep 2023
- Study completion8 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Therapeutic Plasma ExchangeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hesham A Elghoneimy, MD, Principal investigator, Department of internal medicine, nephrology unit, Alexandria faculty of medicine, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06652516
- Sponsor's protocol ID
- IRB NO: 00012098
- Status last verified
- Oct 2024
- First submitted
- 7 Oct 2024
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elghoneimy HA, Elkader MMA, Saad NLM, Tawfiq AA, El-Wakil HS. Study of Centrifugal Therapeutic Plasma Exchange and Membrane Therapeutic Plasma Exchange; A Comparative Study. Ther Apher Dial. 2026 Apr;30(2):210-217. doi: 10.1002/1744-9987.70104. Epub 2025 Dec 21.
PubMed 41422826
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Centrifugal Therapeutic Plasma Exchange and Membrane Therapeutic Plasma Exchange; a Comparative Study
- ClinicalTrials.gov ID
- NCT06652516
- Acronym / sponsor ID
- IRB NO: 00012098
- Conditions
- Therapeutic Plasma Exchange
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 10 Sep 2023 (actual)
- Study completion
- 8 Dec 2023 (actual)
- First posted
- 22 Oct 2024 (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.
This study aims at comparing centrifugation based therapeutic plasma exchange (cTPE) versus membrane based therapeutic plasma exchange (mTPE) as regards performance, effectiveness and adverse events in patients indicated for TPE.
Detailed description
- Study setting: Patients of this study were recruited from the hemodialysis unit of Alexandria Main University Hospital.
- Study design: Randomized prospective crossover study.
- Study population: Twenty patients having clinical indication for TPE.
- They were divided into 2 groups by 1 to 1 randomization Group A: ten patients received the first session of TPE by cTPE and the second session was performed by mTPE 48 hours later.
Group B: ten patients received the first session of TPE by mTPE and the second session was performed by cTPE 48 hours later.
Only the results of 2 sessions for each group were recorded in the study, even if the patients needed further sessions of TPE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cTPE | Active comparator | Procedure: plasma exchangeThis group performed the first session of plasma exchange by centrifugation and the second session by membrane filtration |
| mTPE | Active comparator | Procedure: plasma exchangeThis group performed the first session of plasma exchange by membrane filtration and the second session by centrifugation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients aged more than 18 years old having indication for plasma exchange (based on American Society for Apheresis (ASFA) therapeutic category 1, 2, 3).
- Approval to sign a written consent.
Key exclusion criteria (1 listed)
- Refusal to participate 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| plasma exchangecomparison between the 2 methods of plasma exchange as regards efficacy, performance and adverse events. Procedure of therapeutic plasma exchange (TPE) : mTPE will be done by bellco hemodialysis machine (Formula 2000), while cTPE will be done by Nigale Plasma Collector (XJC 2000). The vascular access used for both types of plasma exchange will be central venous catheter inserted into the internal jugular vein, subclavian or femoral vein. Prescription of TPE The amount of plasma to be treated is usually equivalent to the patient's estimated plasma volume (EPV). Estimated plasma volume will be calculated using the following formula (Kaplan formula) in litres: * EPV = 0.07 x wt (kg) x (1 - hematocrit) in males. * EPV = 0.065 x wt (kg) x (1 - hematocrit) in females. | Procedure or surgery | cTPE, mTPE |
Primary outcome
Time to setup and prime the machine (in minutes)
Time frame: immediately after plasma exchange procedure
Procedure time (in minutes).
Time frame: immediately after plasma exchange procedure
Time to exchange 1 litre of plasma (in minutes).
Time frame: immediately after plasma exchange procedure
Blood flow rate (ml/minutes)
Time frame: immediately after plasma exchange procedure
Plasma removal efficiency (PRE).
Time frame: immediately after plasma exchange procedure
Plasma removal efficiency is an established metric used to analyse the performance of an apheresis device during a TPE procedure. It represents the fraction of plasma that has been removed in a TPE procedure in relation to the plasma that has been processed.
Efficacy in clearance of interleukin 6 and tumor necrosis factor alpha
Time frame: immediately after plasma exchange procedure
serum level of interleukin 6 and tumor necrosis factor apha were assessed before and after each session of therapeutic plasma exchange
Adverse events
Time frame: immediately after plasma exchange procedure
All adverse events occurring during the session were reported including any of the following * Hemolysis. * Urticaria. * Hypotension. * Hypocalcemia. * Clotting of the extracorporeal circuit. * Others.
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 22 Oct 2024.
- Derived from this study: PubMed 41422826Elghoneimy HA, Elkader MMA, Saad NLM, Tawfiq AA, El-Wakil HS. Study of Centrifugal Therapeutic Plasma Exchange and Membrane Therapeutic Plasma Exchange; A Comparative Study. Ther Apher Dial. 2026 Apr;30(2):210-217. doi: 10.1002/1744-9987.70104. Epub 2025 Dec 21.
- Individual participant dataSharing planned: No
Related trials for Therapeutic Plasma Exchange
RecruitingObservational study
Experience With Therapeutic Plasma Exchange in the Pediatric Nephrology Unit of Sohag University Hospital
Experience With Therapeutic Plasma Exchange in the Pediatric Nephrology Unit
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.
Hesham A Elghoneimy, MD principal investigator
Department of internal medicine, nephrology unit, Alexandria faculty of medicine, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing plasma exchange in people with Therapeutic Plasma Exchange, run by Alexandria University at 1 site in Egypt.
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 5 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 22 Oct 2024. 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 Egypt. 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?
Time to setup and prime the machine (in minutes) (time frame: immediately after plasma exchange procedure). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06652516, which also lists 1 linked publication.
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 22 Oct 2024; AzTrials last refreshed its copy on 27 Oct 2026.