56. Jahrestagung der Deutschen Gesellschaft für Transfusionsmedizin und Immunhämatologie

Vorsitz

Prof. Dr.

Therapeutische Apheresen bei neurologischen Erkrankungen

eingeladene Redner

Vortrag

Optimierung der Leukozytensammlung als Ausgangsmaterial für ATMPs

Prof. Dr. Dr.

Einfluss der neuen SoHO Regulation auf die präparative Apherese

Process validation of platelet concentrates and plasma units - Evaluation of three different apheresis devices

Blood Components

Background To further ensure the supply of our oncological patients with platelet concentrates, three different apheresis machines were compared within the scope of a process validation. In addition to measurable product quality, donor feedback and employee handling of equipment are important process components. For this reason, major focus was placed on latter two aspects.Methods As part of the process validation, the critical process parameters (CPP) and critical material attributes (CMA) were used to determine the critical quality attributes (CQA). Besides these measurable quality attributes, questionnaires were used to evaluate the three different apheresis devices by the same donors and operators. It was planned to perform ten thrombocytapheresis and six plasmapheresis procedures with each device. Testing included platelet content, volume, residual cell count, pH, platelet aggregation, sterility, and swirling effect for the platelet concentrates. The following parameters were determined for the obtained plasmas: Residual cell counts, coagulation factor VIII, total protein and sterility.Results see Table 1 The total process time (including set-up times, donation time, post donation activities), the product yield (platelet per unit, single versus double units) and the possibility of plasma donation were identified as particularly relevant CPPs. For the CMAs, the set configuration was identified, in particular the size of the primary label and other additional materials required. Conclusion Based on the results of the surveys and the measured quality control parameters, and taking into account our customer requirements, a clear preference was established from the three apheresis machines evaluated. Device qualification was performed after installation with a total number of 12 additional runs per device.Offenlegung Interessenkonflikt: The authors declare that there is no conflict of interest.Invited talks abstract/summary

Freier Vortrag

Selection of exchange fluid for therapeutic plasma exchange (Leipzig Protocol)

Hemotherapy

Background Therapeutic plasma exchange (TPE) provides evidence-based clinical benefit in a variety of disorders (American Society for Apheresis, DOI: 10.1002/jca.21705). As exchange medium, recommendations reserve fresh frozen plasma for thrombotic thrombocytopenic purpura or to replace clotting factors (e.g. JPAC, United Kingdom; DGTI Section Preparative and Therapeutic Hemapheresis, Germany). Since clear rules are lacking, we initiated a protocol for standardized selection of exchange media in TPE.Methods Patients are categorized into a total of five groups as to liver status, fibrinogen (Fg) levels before TPE and recent (24h) bleeding (see figure 1). Principally, 100% Albumin+crystalline solution is used if Fg is &gt; 1.5 g/l in patients with healthy liver. In patients with liver cirrhosis and if Fg is 1.5-2 g/l with no bleeding events &lt;24h, 50%/50% FFP/Albumin or 100% Albumin plus 2g Fg post TPE i.v. are used. If bleeding is recorded the last 24h or if Fg is &lt;1.5 g/l, 100% GFP is used. Bleeding is assessed according to in-house standards and SOPs.Results We treated a cohort of 26 patients with the following indications for TPE: acute autoimmune exacerbation (n=13), acute liver failure (n=7), suspected or confirmed TTP (n=3), imminent transplant rejection (n=2) and pretransplant conditioning (n=1), representing a total of 132 TPE procedures. The selection procedure for exchange media was applicable throughout and protocol adherence was nearly complete. No increased bleeding tendency or bleeding complications were observed in the patients. Preliminary data show a significantly lower consumption of donor plasma compared to historical controls. Further analysis in currently ongoing including the number of transfusion incidents, and will be further substantiated by ongoing TPEs.Conclusion Our protocol proved feasable and represents a novel instrument to standardize the use of colloids vs FFP in patients undergoing TPE procedures. It is expected to reduce transfusion incidents and immune sensitizations, without exposing patients to additional risks of bleeding complications. Further benefits lie in the preservation of donor plasma, which is a limited source for production of fractionation-derived products. Finally, it should be cost-effective.Offenlegung Interessenkonflikt: keine

MOA 01+02

Sektion Präparative und therapeutische Apherese

Sektionssitzungen

Sektion Präparative und therapeutische Apherese

Termin

Vorsitz

Programm