Skip to main content
OpenTrials
Completed

NCT Number: NCT06652516

Comparison Between Centrifugation Based and Membrane Based Plasma Exchange

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Therapeutic Plasma Exchange

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria university, Faculty of medicine

Alexandria, Egypt

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Refusal to participate in the study.

Treatment and study plan

Plasma Exchange

Procedure

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.

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).

    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.

  6. 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

  7. 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.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Study of Centrifugal Therapeutic Plasma Exchange and Membrane Therapeutic Plasma Exchange; a Comparative Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 22, 2024
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.