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Comparison of early vs late Plasma exchange in the treatment of acute weakness of limbs

Comparison of simultaneous plasma exchange (PLEX) and Intravenous methylprednisolone (IVMPS) versus IVMPS with add on PLEX in the treatment of acute severe myelitis of Neuromyelitis optica spectrum disorders (NMOSD): A prospective randomized open label blinded endpoint (PROBE) study - NA

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/01/061209
Enrollment
30
Registered
2024-01-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G373- Acute transverse myelitis in demyelinating disease of central nervous system

Interventions

Intervention1: simultaneous IVMPS and PLEX group: Patients will be given Intervention2: Simultaneous Therapy: Simultaneous IVMPS and plasma exchange will be started.IVPMS 1 gm/day will be given for 5

Sponsors

ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patient having severe attack of myelitis. 2.MRC power in limb of grade = 2. 3.Patients meet the criteria of NMOSD.

Exclusion criteria

Exclusion criteria: Haemodynamic instability. Coagulopathy. Not giving consent for plasma exchange. Severe or uncontrolled infection. EDSS = 6 due to previous attack of NMOSD. Patient refused to consent for the study.

Design outcomes

Primary

MeasureTime frame
To determine the efficacy of simultaneous PLEX and IVMPS as compared to IVMPS with add on PLEX as treatment of severe attack of acute myelitis of NMOSD.Timepoint: Primary Outcome will be measured at three months of randomization.

Secondary

MeasureTime frame
To determine the efficacy of simultaneous PLEX and IVMPS as compared to IVMPS with add on PLEX, one point improvement in EDSS will be categorised as clinically meaningful improvement.Timepoint: Secondary Outcome will be measured at one and six months of randomization.

Countries

India

Contacts

Public ContactDr Rajesh Kumar Singh

AIIMS

drrajeshrims679@gmail.com01126594049

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026