Comparison Between Centrifugation Based and Membrane Based Plasma Exchange

Study of Centrifugal Therapeutic Plasma Exchange and Membrane Therapeutic Plasma Exchange; a Comparative Study

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.

Study Overview

• Status: Completed
• Conditions: Therapeutic Plasma Exchange
• Intervention / Treatment: Procedure: plasma exchange

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Alexandria university, Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: cTPE; This group performed the first session of plasma exchange by centrifugation and the second session by membrane filtration	Procedure: plasma exchange; comparison between the 2 methods of plasma exchange as regards efficacy, performance and adverse events. Procedure of therapeutic plasma exchange (TPE) : mTPE will be done by bellco hemodialysis machine (Formula 2000), while cTPE will be done by Nigale Plasma Collector (XJC 2000). The vascular access used for both types of plasma exchange will be central venous catheter inserted into the internal jugular vein, subclavian or femoral vein. Prescription of TPE The amount of plasma to be treated is usually equivalent to the patient's estimated plasma volume (EPV). Estimated plasma volume will be calculated using the following formula (Kaplan formula) in litres: EPV = 0.07 x wt (kg) x (1 - hematocrit) in males.; EPV = 0.065 x wt (kg) x (1 - hematocrit) in females.
Active Comparator: mTPE; This group performed the first session of plasma exchange by membrane filtration and the second session by centrifugation	Procedure: plasma exchange; comparison between the 2 methods of plasma exchange as regards efficacy, performance and adverse events. Procedure of therapeutic plasma exchange (TPE) : mTPE will be done by bellco hemodialysis machine (Formula 2000), while cTPE will be done by Nigale Plasma Collector (XJC 2000). The vascular access used for both types of plasma exchange will be central venous catheter inserted into the internal jugular vein, subclavian or femoral vein. Prescription of TPE The amount of plasma to be treated is usually equivalent to the patient's estimated plasma volume (EPV). Estimated plasma volume will be calculated using the following formula (Kaplan formula) in litres: EPV = 0.07 x wt (kg) x (1 - hematocrit) in males.; EPV = 0.065 x wt (kg) x (1 - hematocrit) in females.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to setup and prime the machine (in minutes)		immediately after plasma exchange procedure
Procedure time (in minutes).		immediately after plasma exchange procedure
Time to exchange 1 litre of plasma (in minutes).		immediately after plasma exchange procedure
Blood flow rate (ml/minutes)		immediately after plasma exchange procedure
Plasma removal efficiency (PRE).	Plasma removal efficiency is an established metric used to analyse the performance of an apheresis device during a TPE procedure. It represents the fraction of plasma that has been removed in a TPE procedure in relation to the plasma that has been processed.	immediately after plasma exchange procedure
Efficacy in clearance of interleukin 6 and tumor necrosis factor alpha	serum level of interleukin 6 and tumor necrosis factor apha were assessed before and after each session of therapeutic plasma exchange	immediately after plasma exchange procedure
Adverse events	All adverse events occurring during the session were reported including any of the following; Hemolysis.; Urticaria.; Hypotension.; Hypocalcemia.; Clotting of the extracorporeal circuit.; Others.	immediately after plasma exchange procedure

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: Hesham A Elghoneimy, MD, Department of internal medicine, nephrology unit, Alexandria faculty of medicine, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2023
• Primary Completion (Actual): September 10, 2023
• Study Completion (Actual): December 8, 2023

Study Registration Dates

• First Submitted: October 7, 2024
• First Submitted That Met QC Criteria: October 19, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Actual): October 22, 2024
• Last Update Submitted That Met QC Criteria: October 19, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IRB NO: 00012098

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No