In Vitro Characterization of Solvent/Detergent‐Treated Human Plasma and of Quarantine Fresh Frozen Plasma

Abstract

Background and objectives: Plasma pools, solvent/detergent(S/D)‐treated plasma produced from plasma pools, and single donor fresh frozen plasma that had been quarantined for at least 6 months (QFFP) differ in their composition regarding clotting factors, inhibitors and other important plasma proteins. There are poor data concerning stability of important clotting factors after thawing of frozen plasma units. Materials and methods: 12 plasma pools, 12 batches of S/D plasma produced from these respective plasma pools, and 12 units of QFFP were extensively analysed. The stability of fibrinogen and factors V, VII, and VIII after thawing, storage at room temperature and at +4°C was also examined. Results: We extensively analysed plasma pools before and after solvent/detergent treatment as well as quarantined single donor plasma units for parameters of coagulation and fibrinolysis. After the S/D step, all clotting factor activities and the activities of most inhibitors and other plasma proteins were in the normal range in all batches. Protein S and plasmin inhibitor activities decreased by 35% and 76%, respectively. S/D treatment partly activated factor VII (FVII). However, there were no marked increases of other markers of activated hemostasis. The interindividual variations of all proteins analysed were significantly lower in the S/D plasmas than in the single donor plasma units. An 8‐hour storage lead to a marked decrease of FVIII activity, whereas there was no significant influence on fibrinogen and factors V and VII. Conclusions: There are no critical reductions of the activities of clotting factors, inhibitors, and other important plasma proteins due to S/D treatment. Efficacy and safety of S/D plasma is not hampered by reduced activities of protein S and plasmin inhibitor. Dosage calculation and the evaluation of clinical response is simplified by usage of the more standardized S/D plasma compared to QFFP.