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CompletedNCT06652516Updated Oct 22, 2024

Comparison Between Centrifugation Based and Membrane Based Plasma Exchange

An interventional study of plasma exchange in Therapeutic Plasma Exchange, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-10-22.

Sponsored by Alexandria University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Jan 2023, registered Oct 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Therapeutic Plasma Exchange
03

In context

Lead sponsor

Alexandria University is the lead sponsor of 569 studies on the registry; 125 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Refusal to participate in the study.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    cTPE

    This group performed the first session of plasma exchange by centrifugation and the second session by membrane filtration

    Procedure: plasma exchange

  • Active comparator
    mTPE

    This group performed the first session of plasma exchange by membrane filtration and the second session by centrifugation

    Procedure: plasma exchange

Interventions

  • Procedureplasma exchange

    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.

06

What researchers measure

Primary outcomes

  1. Time to setup and prime the machine (in minutes)

    Time frame: immediately after plasma exchange procedure

  2. Procedure time (in minutes).

    Time frame: immediately after plasma exchange procedure

  3. Time to exchange 1 litre of plasma (in minutes).

    Time frame: immediately after plasma exchange procedure

  4. Blood flow rate (ml/minutes)

    Time frame: immediately after plasma exchange procedure

  5. 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.

    Time frame: immediately after plasma exchange procedure

  6. 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

    Time frame: immediately after plasma exchange procedure

  7. 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.

    Time frame: immediately after plasma exchange procedure

07

Study locations

1 site
  • Alexandria university, Faculty of medicine
    Alexandria, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06652516
Lead sponsor
Alexandria University
Responsible party
Sponsor
First posted
Oct 22, 2024
Start date
Jan 5, 2023
Primary completion
Sep 10, 2023
Completion
Dec 8, 2023
Last update
Oct 22, 2024

Study contacts

Hesham A Elghoneimy, MD
principal investigator · Department of internal medicine, nephrology unit, Alexandria faculty of medicine, Egypt

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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