Background: Fresh-frozen plasma (FFP) is a widely used blood transfusion product. The transfusion safety of this product is ensured by legally obligatory tests, but can be further improved by using some technical procedures, such as methylene blue (MB) and solvent-detergent (SD) viral inactivation methods. Mainly organisational criteria led us to introduce the SD viral inactivation technique as a service activity. In this report we describe our first year of experience, following the introduction of the SD technique, and thus the use of SD-virally inactivated plasma (PlasmaSafe).
Materials and methods: IN ORDER TO EVALUATE THE APPROPRIATE USE AND THE THERAPEUTIC EFFICACY OF PLASMASAFE IN OUR BLOOD TRANSFUSION UNIT, THE FOLLOWING PROGRAMME WAS PLANNED: quality control [prothrombin time (PT), activated partial thromboplastin time (aPTT), fibrinogen] of the FFP units (N=312); evaluation of the clinical effectiveness on 490 patients (879 transfusion events); pre- and post-treatment monitoring of indicators of coagulation (PT, aPTT, fibrinogen, proteins S and C, factor VIII) on 15 patients; treatment of three patients with thrombotic thrombocytopenic purpura (TTP) undergoing plasma-exchange; haemovigilance of adverse reactions provoked by SD-plasma.
Results: THE INDICATORS OF COAGULATION IN THE FFP UNITS VARIED GREATLY: the PT ranged from 50-120%, the aPTT from 24-41 seconds and the fibrinogen concentration from 1.42-6.84 g/L. Seventy-six percent of the patients responded to the plasma administration; moreover, two of 15 patients in whom protein S was assayed, showed no increase of this haemostatic protein. The TTP patients responded to plasma exchange treatment following four sessions of apheresis. During the observation period 8,422 PlasmaSafe units were transfused and no adverse reactions were recorded.
Conclusion: PlasmaSafe, a pharmaceutical-like product with a standardised content of coagulation factors, was found to be effective at correcting coagulation defects and for treating TTP. No thrombotic complications or transfusion-related adverse reactions were recorded.
Keywords: PlasmaSafe; Solvent-detergent technique; clinical effectiveness; haemovigilance.