Comparison Between Centrifugation Based and Membrane Based Plasma Exchange

Alexandria University

Status: Completed

Conditions: Therapeutic Plasma Exchange

Treatments: Procedure: plasma exchange

Study type: Interventional

Funder types: Other

Identifiers

NCT06652516

IRB NO: 00012098

Details and patient eligibility

About

This study aims at comparing centrifugation based therapeutic plasma exchange (cTPE) versus membrane based therapeutic plasma exchange (mTPE) as regards performance, effectiveness and adverse events in patients indicated for TPE.

Full description

• Study setting: Patients of this study were recruited from the hemodialysis unit of Alexandria Main University Hospital.
• Study design: Randomized prospective crossover study.
• Study population: Twenty patients having clinical indication for TPE.
• They were divided into 2 groups by 1 to 1 randomization Group A: ten patients received the first session of TPE by cTPE and the second session was performed by mTPE 48 hours later.

Group B: ten patients received the first session of TPE by mTPE and the second session was performed by cTPE 48 hours later.

Only the results of 2 sessions for each group were recorded in the study, even if the patients needed further sessions of TPE.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients aged more than 18 years old having indication for plasma exchange (based on American Society for Apheresis (ASFA) therapeutic category 1, 2, 3).

  • Category I: includes disorders for which TPE is accepted as first-line therapy, either as primary stand-alone treatment or in conjunction with other modes of treatment. Examples include Guillain-Barre syndrome, acquired thrombotic thrombocytopenic purpura, and erythrocytapheresis in sickle cell diseases with certain complications (eg, stroke).
  • Category II: includes disorders for which TPE is accepted as second-line therapy, either as a stand-alone treatment or in conjunction with other modes of treatment. Examples include life-threatening hemolytic anemia for cold agglutinin disease or Lambert-Eaton myasthenic syndrome.
  • Category III: includes disorders for which the optimum role of apheresis therapy is not established. Decision making should be individualized. Examples include TPE for hyper-triglyceridemic pancreatitis or extracorporeal photopheresis for nephrogenic systemic fibrosis.

• Approval to sign a written consent.

Exclusion criteria

• Refusal to participate in the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups

cTPE

Active Comparator group

Description:

This group performed the first session of plasma exchange by centrifugation and the second session by membrane filtration

Treatment:

Procedure: plasma exchange

mTPE

Active Comparator group

Description:

This group performed the first session of plasma exchange by membrane filtration and the second session by centrifugation

Treatment:

Procedure: plasma exchange