NCT06652516

Comparison Between Centrifugation Based and Membrane Based Plasma Exchange

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-01-05
• Primary completion: 2023-09-10
• Completion: 2023-12-08
• First posted: 2024-10-22
• Last updated: 2024-10-22

Locations

1 site across 1 country: Egypt