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The predictive model of therapeutic plasma exchange in acute exacerbation of AChR-Ab positive myasthenia gravis

The predictive model of therapeutic plasma exchange in acute exacerbation of AChR-Ab positive myasthenia gravis

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100043920
Enrollment
Unknown
Registered
2021-03-05
Start date
2021-03-05
Completion date
Unknown
Last updated
2021-07-12

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

Conditions

Neuroimmune disease

Interventions

Myasthenia crisis or pre crisis state group:Nil
MG stable group:Nil
Healthy control group:Nil

Sponsors

The First Affiliated Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. TPE group: diagnosis with AChR-Ab positive MG, and in myasthenia crisis or pre-crisis state (diagnostic criteria meet the 2016 MGFA International Guidelines); >= 16 years old. 2. MG case control group: diagnosis as AChR-Ab positive MG, and MGFA classification is II~III (diagnostic criteria conform to 2016 MGFA international guidelines); >= 16 years old; without treatment history of immunosuppressive (cholinesterase inhibitor may be used). 3. Healthy control group: healthy people with age and sex matched with TPE treatment group and without autoimmune/rheumatic diseases; no tumor-related medical history.

Exclusion criteria

Exclusion criteria: TPE group: TPE contraindications before standard treatment (unstable circulation, systolic blood pressure < 90mmHg or diastolic blood pressure < 60mmHg, severe abnormal coagulation fibrinogen < 0.8 g/L or platelet < 50 x 10^9/L). Eight weeks before including, treatment with IVMP or IVIG; existence of other malignant tumors except thymoma. The other two control groups: existence of other malignant tumors except thymoma.

Design outcomes

Primary

MeasureTime frame
AChR-Ab;C3,C5;IL-2,4,6,10;Lymphocyte subsets;QMGs;

Countries

China

Contacts

Public ContactHuiyu Feng

The First Affiliated Hospital of Sun Yat-sen University

fenghuiy@mail.sysuedu.cn+86 13247594957

Outcome results

None listed

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