Evaluation for Therapeutic Plasma Exchange for Immune Mediated Neurological Disease (TPE)

November 15, 2025 updated by: Wajdi Hamid Miftah Eisay, Al-Azhar University

Evaluation of Therapeutic Plasma Exchange for Immune-Mediated Neurological Diseases in a Sample of Egyptian Patients: An Experience at Al-Azhar University Hospitals

The goal of this observational study is to Evaluation of Therapeutic Plasma Exchange for Immune-Mediated Neurological Diseases in a Sample of Egyptian Patients: An Experience at Al-Azhar University Hospitals, including evaluating clinical response rates and functional improvement.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Therapeutic plasma exchange (TPE) is recommended as Class I therapies by the American Society for Apheresis (ASFA) guidelines and are widely used as first-line therapies for the treatment of acute neuroimmune diseases , TPE is generally well tolerated, with minor complications occurring in about 20-30% of patients ,(ASFA) publishes regular guidelines on the indications for TPE. Studies performed over the last three decades showed that myasthenia gravis (MG), Guillain-Barre syndromé (GBS) and chronic inflammatory demyelinating polyneuropathy (CIDP) were the most frequently cited indications for TPE followed by multiple sclerosis (MS) , The aims of this research to evaluate therapeutic plasma exchange for immune-mediated neurological diseases in a sample of Egyptian patients, including evaluating clinical response rates and functional improvement

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Hussein Mohammed Hussein, Professor
  • Phone Number: 00201005196285

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Al-Azhar University Hospitals
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

An Experience at Al-Azhar University Hospitals (Al-Hussein & Sayed Galal) in Egypt

Description

Inclusion Criteria:

  • 1. All neurological patients irrespective of age who will undergo TPE. 2.All new and relapse cases that meet the ASFA guidelines and where TPE is the first and/or second line of therapy

Exclusion Criteria:

  • 1. Individuals with contraindications to therapeutic plasma exchange, such as hemodynamic unstable, hypocalcaemia, allergy to fresh frozen plasma or albumin.

    2.Patients who will undergo fewer than five cycles of TPE and not complete the procedure.

    3.Patients with non-neurological disorders.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Rankin Scale (mRS)
Time Frame: will be conducted on each patient on two occasions: prior to and one month subsequent to the completion of plasmapheresis.
The mRS will be rated as follows: 0, no symptoms; 1, no substantial disability; 2, slight disability; 3, moderate disability; 4, moderately severe disability; 5, severe disability; and 6, deceased.
will be conducted on each patient on two occasions: prior to and one month subsequent to the completion of plasmapheresis.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Actual)

October 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

September 20, 2025

First Submitted That Met QC Criteria

September 20, 2025

First Posted (Estimated)

September 29, 2025

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 15, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 000110

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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