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Recruiting NCT07197099

Evaluation for Therapeutic Plasma Exchange for Immune Mediated Neurological Disease

Observational Neurological Autoimmune Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Neurological Autoimmune Diseases. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

Primary outcome measures

  • 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Egypt · 1 center
  • Al-Azhar University Hospitals — Cairo

Identifiers

NCT: NCT07197099 · 000110

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗