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Specific clinical study on the safety of replacement fluids using hypertonic albumin solutions in plasma exchange therapy(Alb-PE-01)

Specific clinical study on the safety of replacement fluids using hypertonic albumin solutions in plasma exchange therapy(Alb-PE-01)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs071250083
Enrollment
20
Registered
2025-10-08
Start date
2026-04-16
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Myasthenia gravis, Systemic lupus erythematosus, CIDP etc

Interventions

Medication (new replacement fluid)

Sponsors

Adachi Masataka
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The study is open to those who meet all of the following criteria: - Patients (regardless of gender) who require inpatient treatment and simple plasma exchange therapy - Patients aged 18 years or older who have provided written consent from themselves or their legal representative

Exclusion criteria

Exclusion criteria: Those who meet the following criteria will be excluded: - Those deemed inappropriate as subjects of this study by the principal investigator.

Design outcomes

Primary

MeasureTime frame
The Incidence rate of adverse events and side effects occurring during plasma exchange treatment

Secondary

MeasureTime frame
(1)Safety Evaluation - Changes in vital signs measured before, during, and after plasma exchange - Changes in the following laboratory values measured before and after plasma exchange. Blood gas analysis also performed during plasma exchange Albumin level, Fibrinogen level, Electrolytes( Na, K, Ca, Mg, Cl, P) Blood gases(Bicarbonate ion ( HCO3-), ionized calcium concentration, pH (2)Efficacy Evaluation - Changes in the following laboratory values measured before and after plasma exchange Antibody levels( IgG,IgM,IgA)

Contacts

Public ContactMasataka Adachi

Kumamoto University Hospital

m-adachi@gpo.kumamoto-u.ac.jp+81-96-373-5164

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026