Comparison Between Centrifugation Based and Membrane Based Plasma Exchange

NCT ID: NCT06652516

Last Updated: 2024-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-05
• Study Completion Date: 2023-12-08

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.

Conditions

Therapeutic Plasma Exchange

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

cTPE

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

Group Type: ACTIVE_COMPARATOR

plasma exchange

Intervention Type: PROCEDURE

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.

mTPE

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

Group Type: ACTIVE_COMPARATOR

plasma exchange

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hesham A Elghoneimy, MD

Role: PRINCIPAL_INVESTIGATOR

Department of internal medicine, nephrology unit, Alexandria faculty of medicine, Egypt

Locations

Alexandria university, Faculty of medicine

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

IRB NO: 00012098

Identifier Type: -

Identifier Source: org_study_id