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A trial to compare two treatment options for Landry Guillain Barre Syndrome (A form of paralysis) in children

THERAPEUTIC PLASMA EXCHANGE VERSUS INTRAVENOUS IMMUNOGLOBULIN IN CHILDREN WITH LANDRY GUILLAIN BARRE SYNDROME â?? AN OPEN LABEL, RANDOMIZED CONTROLLED TRIAL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/12/029502
Enrollment
34
Registered
2020-12-02
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: G610- Guillain-Barre syndrome

Interventions

Intervention1: Therapeutic Plasma Exchange: TPE will be performed on automated cell separator: Spectra Optia® (Terumo BCT Lakewood, CO) after an informed consent from patientsâ?? parents/guardians. P

Sponsors

Manjinder Singh Randhawa
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Admitted with a diagnosis of Landry Guillain Barre Syndrome 2. Requiring Mechanical Ventilation 3. Presentation <14 days from onset of symptoms

Exclusion criteria

Exclusion criteria: 1. Treatment with IvIg or PE prior to admission 2. History of prior episode of LGBS 3. Patients with known malignancy, AIDS, IgA deficiency 4. Patients with a known chronic neurological/neuromuscular disorder 5. Patients with a known Renal Failure/Cardiac dysfunction 6. Patients with a history of a transfusion reaction

Design outcomes

Primary

MeasureTime frame
To compare the mean duration of mechanical ventilation among ventilated children less than12 years of age with Landry Guillain Barre Syndrome who undergo Therapeutic Plasma Exchange (5 Cycles) with those who receive Intravenous Immunoglobulin (@ 2g/kg)Timepoint: To compare the mean duration of mechanical ventilation among ventilated children less than12 years of age with Landry Guillain Barre Syndrome who undergo Therapeutic Plasma Exchange (5 Cycles) with those who receive Intravenous Immunoglobulin (@ 2g/kg)

Secondary

MeasureTime frame
Adverse Effects of therapy in the two groupsTimepoint: Till discharge/death;All Cause MortalityTimepoint: Till discharge/death;Duration of PICU stayTimepoint: Continuous variable;Functional score (Hughes Score)Timepoint: At PICU discharge, Hospital discharge and 3 months;Healthcare Associated InfectionsTimepoint: Till discharge/death;Time to improvement of one grade in Hughes scoreTimepoint: Continuous variable;Time to walk unaidedTimepoint: Continuous variable

Countries

India

Contacts

Public ContactManjinder Singh Randhawa

Post Graduate Institute of Medical Education and Research

drarunbansal@gmail.com9815455002

Outcome results

None listed

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