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NCT Number: NCT07197099

Evaluation for Therapeutic Plasma Exchange for Immune Mediated Neurological Disease

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hussein Mohammed Hussein, Professor

CONTACT

00201005196285

Wajdi Hamid Eisay, MD

CONTACT

[email protected]

00218911103885

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Acronym: TPE

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 29, 2025
Registry last updated
Nov 18, 2025

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.

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