Efficacy of Intravenous Gamma Globulin on Guillain-Barre Syndrome

An Observational Cohort Study on the Efficacy of Intravenous Gamma Globulin on Guillain-Barre Syndrome

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04303962

Enrollment

200

Registered

2020-03-11

Start date

2020-04-27

Completion date

2025-01-21

Last updated

2022-01-19

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

Conditions

Guillain-barre Syndrome

Brief summary

Guillain-barre syndrome (GBS) is an acute immune-mediated polyneuropathy. Intravenous Gamma globulin is an effective therapy.Although high doses of gamma globulin are clinically effective, the patient's recovery and clinical prognosis vary. The establishment of a cohort study on the therapeutic effect of gamma globulin in Guillain-barre Syndrome is beneficial to the diagnosis of the disease and to the understanding of the natural course of the disease and the efficacy of drug treatment.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Meet the Brighton Guillain-Barre Syndrome diagnosis criteria in 2014; 2. Age ≥18; 3. Patients with AIDP, AMAN and AMSAN; 5\. IVIG was treated within 2 weeks of onset; 6. GBS disability scale\>2; 6. Cooperate with patients who were followed up for 180 days and sign the informed consent;

Exclusion criteria

1. Age \<18; 2. Pregnant or nursing women; 3. Patients with Chronic inflammatory demyelinating multiple peripheral neuropathy; 4. Combined with other types of immune system diseases; 5. Accept drugs that affect the function of the immune system within 5 or 3 months; 6. Concomitant neoplastic diseases. 7. The patient or guardian refused to sign the informed consent.

Design outcomes

Primary

Measure	Time frame	Description
GBS disability score	6 months	GBS disability scale ( Guillain-Barré syndrome disability scale) was defined as follows: 0: healthy state; 1: minor symptoms and capable of running; 2: able to walk 5 meters or more without assistance but unable to run; 3: able to walk 5 meters across an open space with help; 4: bedridden or chair-bound; 5: requiring assisted ventilation for at least part of the day; 6: dead

Secondary

Measure	Time frame	Description
Respiratory function	6 months	whether mechanical ventilation is required

Countries

China

Contacts

Primary ContactZhu MD Jiitng, PhD

zjtzjt11@yeah.net13559947905

Backup ContactYing Fu, PhD

fuying1995@163.com+8613920263688

Outcome results