NCT07197099

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 29, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

November 18, 2025

Status Verified

September 1, 2025

Enrollment Period

10 months

First QC Date

September 20, 2025

Last Update Submit

November 15, 2025

Conditions

Neurological Autoimmune Diseases

Outcome Measures

Primary Outcomes (1)

  • Modified Rankin Scale (mRS)

    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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • \. 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

You may not qualify if:

  • \. Individuals with contraindications to therapeutic plasma exchange, such as hemodynamic unstable, hypocalcaemia, allergy to fresh frozen plasma or albumin.
  • Patients who will undergo fewer than five cycles of TPE and not complete the procedure.
  • Patients with non-neurological disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar University Hospitals

Cairo, Egypt

RECRUITING

Central Study Contacts

Wajdi Hamid Eisay, MD

CONTACT

00218911103885wajdyessa91@gmail.com

Hussein Mohammed Hussein, Professor

CONTACT

00201005196285

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident

Study Record Dates

First Submitted

September 20, 2025

First Posted

September 29, 2025

Study Start

January 1, 2025

Primary Completion

October 30, 2025

Study Completion

December 31, 2025

Last Updated

November 18, 2025

Record last verified: 2025-09

Locations

EG(1)