Evaluation for Therapeutic Plasma Exchange for Immune Mediated Neurological Disease

Recruiting

• Conditions: Neurological Autoimmune Diseases

• Registration Number: NCT07197099
• Lead Sponsor: Al-Azhar University

Brief Summary

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.

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 Timeline

• Study Start: 2025-01-01
• Status Verified: 2025-09
• Study First Submitted: 2025-09-20
• Study First Submitted QC: 2025-09-20
• Last Update Submitted: 2025-09-20
• Study First Posted: 2025-09-29
• Last Update Posted: 2025-09-29
• Primary Completion: 2025-10-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Modified Rankin Scale (mRS)	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.

Trial Locations

Locations (1)

Al-Azhar University Hospitals; 🇪🇬 Cairo, Egypt