Clinical trial NCT06652516: Comparison Between Centrifugation Based and Membrane Based Plasma Exchange
Official title: Study of Centrifugal Therapeutic Plasma Exchange and Membrane Therapeutic Plasma Exchange; a Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Therapeutic Plasma Exchange
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to setup and prime the machine (in minutes)
timeFrame: immediately after plasma exchange procedure
measure: Procedure time (in minutes).
timeFrame: immediately after plasma exchange procedure
measure: Time to exchange 1 litre of plasma (in minutes).
timeFrame: immediately after plasma exchange procedure
measure: Blood flow rate (ml/minutes)
timeFrame: immediately after plasma exchange procedure
measure: Plasma removal efficiency (PRE).
timeFrame: immediately after plasma exchange procedure
measure: Efficacy in clearance of interleukin 6 and tumor necrosis factor alpha
timeFrame: immediately after plasma exchange procedure
measure: Adverse events
timeFrame: immediately after plasma exchange procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria university, Faculty of medicine
Study officials:
affiliation: Department of internal medicine, nephrology unit, Alexandria faculty of medicine, Egypt
name: Hesham A Elghoneimy, MD
role: PRINCIPAL_INVESTIGATOR
References: