Comparison Between Centrifugation Based and Membrane Based Plasma Exchange

NCT06652516 | Completed

• 1 other identifier: IRB NO: 00012098
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Therapeutic Plasma Exchange

Outcome Measures

Primary Outcomes (7)

• Time to setup and prime the machine (in minutes)

  immediately after plasma exchange procedure

• Procedure time (in minutes).

  immediately after plasma exchange procedure

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

  immediately after plasma exchange procedure

• Blood flow rate (ml/minutes)

  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.

  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

  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.

  immediately after plasma exchange procedure

Study Arms (2)

cTPE

ACTIVE COMPARATOR

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

Procedure: plasma exchange

mTPE

ACTIVE COMPARATOR

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

Procedure: plasma exchange

Interventions

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.

cTPE; mTPE

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Refusal to participate in the study.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria university, Faculty of medicine

Alexandria, Egypt

Location

Related Publications (1)

• 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. 2025 Dec 21. doi: 10.1002/1744-9987.70104. Online ahead of print.

  PMID: 41422826 DERIVED

MeSH Terms

Interventions

Plasma Exchange

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics; Plasmapheresis; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Hesham A Elghoneimy, MD

  Department of internal medicine, nephrology unit, Alexandria faculty of medicine, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 22, 2024
• Study Start: January 5, 2023
• Primary Completion: September 10, 2023
• Study Completion: December 8, 2023
• Last Updated: October 22, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)