Therapeutic Plasma Exchange
Conditions
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.
Interventions
PROCEDUREplasma 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.
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | immediately after plasma exchange procedure | 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. |
| Efficacy in clearance of interleukin 6 and tumor necrosis factor alpha | immediately after plasma exchange procedure | serum level of interleukin 6 and tumor necrosis factor apha were assessed before and after each session of therapeutic plasma exchange |
| Adverse events | immediately after plasma exchange procedure | All adverse events occurring during the session were reported including any of the following * Hemolysis. * Urticaria. * Hypotension. * Hypocalcemia. * Clotting of the extracorporeal circuit. * Others. |
Countries
Egypt
Outcome results
None listed