Intravenous immunoglobulin for preparing myasthenia gravis patients for thymectomy and other surgical procedures preventing myasthenic crisis.

Conditions: Myasthenia gravis
MedDRA version: 15.0Level: PTClassification code 10028417Term: Myasthenia gravisSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2012-001544-21-ES

Lead Sponsor: Vall d'Hebron Institut de Recerca (VHIR)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 84

Inclusion Criteria

Age >18 years, diagnostic of myasthenia gravis and surgical procedures requiring general anesthesia, including thymectomy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 42
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 42

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: preoperatively administered intravenous immunoglobulin (IVIg) is an effective preparatory measure for reducing the incidence of myasthenic crises;Secondary Objective: To evaluate the length of the hospital stay and functional status measured by the MGFA;Primary end point(s): incidence of myasthenic crises;Timepoint(s) of evaluation of this end point: After surgery and every day while the patient remains in hospital

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): length of the hospital stay and functional status measured by the MGFA;Timepoint(s) of evaluation of this end point: After surgery and every day while the patient remains in hospital