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Comparison of two protocols with two different doses of albumin in plasmapheresis.

Comparing the effectiveness and safety of two protocols with different dose of albumin in plasma exchange of patients with neurological inflammatory disorders requiring plasmapheresis; a Randomized Blinded, Non-inferiority Controlled Trial.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20191115045446N2
Enrollment
60
Registered
2025-06-07
Start date
2025-06-21
Completion date
Unknown
Last updated
2025-07-21

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

Conditions

Patients with neurological disorders requiring plasmapheresis..

Interventions

Intervention 1: Intervention group: For every 1500 milliliters of plasma replacement, two vials of 20% albumin and 1400 milliliters of normal saline will be administered in each PLEX session. Interven

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients with inflammatory neurological syndromes who are candidates for plasma exchange. Adult patients aged 18 to 65 years Serum albumin level above 3 g/dL.

Exclusion criteria

Exclusion criteria: Pregnant and breastfeeding patients. Patients with heart failure, liver failure, and kidney failure (patients with nephrotic syndrome) Cirrhotic patients. Patients with cachexia and malnutrition with BMI < 17.5. Patients in an unstable hemodynamic condition, such as septic shock, acute respiratory failure, pulmonary embolism, or hypotension (systolic blood pressure below 90 mmHg). Thrombocytopenia with PLT < 100,000.

Design outcomes

Primary

MeasureTime frame
Colloid Osmotic Pressure. Timepoint: Before the start of plasmapheresis and after the completion of the last session of plasmapheresis. Method of measurement: Calculation via formula: Colloid Osmotic Pressure = (Globulin in g/dl * 1.4) + (Albumin in g/dl *5.5).

Secondary

MeasureTime frame
The level of edema based on visual examination. Timepoint: Before the start of plasmapheresis sessions and after the completion of each plasmapheresis session. Method of measurement: visual examination.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHadi Esmaily

Shahid Beheshti University of Medical Sciences

Esmaily_hadi@sbmu.ac.ir+98 21 8887 3704

Outcome results

None listed

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