EPTACOG ALFA. APPLICATION EXPERIENCE

Author(s):  
И. Нехаев ◽  
А. Приходченко ◽  
С. Ломидзе ◽  
А. Сытов

Введение. Несмотря на переливания свежезамороженной плазмы и тромбоцитов, часто не удается достигнуть нужной «пороговой» концентрации факторов свертывания при массивных кровотечениях. При введении рекомбинантного активированного VII фактора (rFVIIa, эптаког альфа) этот процесс может быть ускорен, происходит «тромбиновый взрыв», который обеспечивает образование стабильной фибриновой пробки. Цель исследования: оценка эффективности и безопасности применения rVIIа в онкохирургии при коагулопатических кровотечениях. Материалы и методы. Обследовано 38 пациентов, оперированных по поводу злокачественных новообразований различной локализации, находившихся на лечении в отделении реанимации и интенсивной терапии № 1 в течение 2014 года. Результаты. Клиническая эффективность rFVIIа составила 94,7% при неэффективности стандартной гемостатической терапии и исчерпанных возможностях хирургического гемостаза при коагулопатических кровотечениях у онкохирургических больных. Заключение. rFVIIа обладает селективным действием (действует в зоне повреждения), что подтверждают данные коагулограммы и тромбоэлаcтометрии. rFVIIа не утяжеляет состояния больных. Introduction. Despite the transfusion of fresh frozen plasma and platelets it is often not possible to achieve the desired «threshold» concentration of coagulation factors in case of acute massive bleeding. Administration of recombinant activated VII factor (rFVIIa, eptacog alfa) can accelerates this process; «thrombin burst» occurs that provides the formation of a stable fi brin plug. Aim: to assess the effectiveness and safety of rVIIa usage in oncosurgery at coagulopathic bleedings. Materials and methods. In intensive care unit during 2014 we examined 38 patients with malignant tumors of various locations after surgery. Results. Clinical efficacy of rFVIIa was 94,7% with ineffectiveness of standard hemostatic therapy and exhausted possibilities of surgical hemostasis with coagulopathic bleedings in oncosurgical patients. Conclusion. rFVIIa has a targeted action (acts in damage area); coagulogram and thromboelometry data prove its action. rFVII does not make patients worse.

Author(s):  
И.А. Кривов ◽  
А.А. Рагимов ◽  
Э.Л. Салимов

Введение. Свежезамороженная плазма (СЗП) — один из самых распространённых компонентов крови, применяемых сегодня в клиниках при оказании медицинской помощи при кровотечениях и тяжёлых коагулопатиях. В отличие от вирусинактивированной замороженной плазмы, сублимированная (лиофилизированная) плазма может храниться при комнатной температуре, и восстановление перед переливанием обычно требует меньших временных затрат. Цель исследования: оценить коагуляционный потенциал лиофилизированной плазмы, полученной из вирусинактивированной плазмы, инактивированной 2 способами: с использованием метиленового синего + видимый свет и рибофлавина + ультрафиолетовое облучение спектра B. Материалы и методы. Проведен анализ 100 образцов иофилизированной плазмы, вирусинактивированной двумя методами. Изучали влияние лиофилизации на уровень факторов свертывания и показатели свертываемости в вирусинактивированной плазме. Для сравнительной оценки в качестве контроля были проанализированы 150 образцов СЗП. Результаты. При использовании обоих технологий инактивации в лиофилизированной вирусинактивированной плазме установлено снижение содержания факторов V и VIII как по отношению к СПЗ, так и по отношению к физиологической норме. Лиофилизация вирусинактивированной плазмы различными методами привела к некоторому увеличению показателей свёртывания крови — протромбинового времени и активированного частичного тромбопластинового времени. Остальные показатели оставались в нормальных пределах. Существенных различий в показателях между образцами плазмы, инактивированной различными методами, выявлено не было. Заключение. По клиническим свойствам вирусинактивированная лиофилизированная плазма может служить альтернативой СЗП, однако для уточнения всесторонних аспектов её применения необходимы дополнительные исследования. Introduction. Fresh frozen plasma (FFP) is one of the most common blood components used today in clinics for medical care of bleeding and severe coagulopathies. Unlike virus-inactivated frozen plasma, sublimated (lyophilized) plasma can be stored at room temperature, and recovery before transfusion usually requires less time. Objectives: to assess the coagulation potential of lyophilized plasma obtained from virus- inactivated plasma inactivated by 2 methods: using methylene blue + visible light and riboflavin + ultraviolet radiation of spectrum B. Materials/Methods. Analysis of 100 samples of lyophilized plasma, virus-inactivated by 2 methods, was carried out. The effect of lyophilization on the level of coagulation factors and coagulation parameters in virus-inactivated plasma was studied. For comparative evaluation, 150 samples of FFP were analyzed as a control. Results. Using both technologies for inactivation of lyophilized virus- inactivated plasma, a decrease in the content of V and VIII factors was found both in relation to the FFP and in relation to the physiological norm. Lyophilization of virus-inactivated plasma by various methods led to a slight increasing in blood coagulation parameters — prothrombin time and activated partial thromboplastin time. The rest of the parameters remained within normal limits. There were no significant differences in parameters between plasma samples inactivated by different methods. Conclusions. According clinical properties, virus- inactivated lyophilized plasma can serve as an alternative to FFP, but more studies are needed to clarify the comprehensive aspects of its use.


2006 ◽  
Vol 26 (S 02) ◽  
pp. S3-S14 ◽  
Author(s):  
P. Innerhofer

SummaryGuidelines of official societies for diagnosis and therapy of intraoperatively occurring hypocoagulability rely mainly on data of patients receiving whole blood transfusions. They recommend -provided that laboratory evaluation shows deficiency (values >1.5 fold normal)- administration of fresh frozen plasma, cryoprecipitate and platelet concentrates (platelet count <50 000 or <100 000/μl). This article describes the pathogenesis of coagulopathy in the light of the special intraoperative setting, emphasizes recent changes of blood component preparation, transfusion triggers, effects of volume therapy and challenges standard laboratory assays as reliable guide for intraoperative hemostatic therapy. The role of thrombelastographic monitoring is discussed as well as an alternative strategy to compensate deficiencies by the use of coagulation factor concentrates instead of or in addition to transfusion of FFP, a new concept which is illustrated by the presentation of an actual case report.


2016 ◽  
Vol 62 (4) ◽  
pp. 545-551
Author(s):  
Akihiro Fuchizaki ◽  
Jumpei Mori ◽  
Akira Iwama ◽  
Masayuki Shiba ◽  
Yu Naito ◽  
...  

2012 ◽  
Vol 19 (4) ◽  
pp. 453-459 ◽  
Author(s):  
Bernhard Ziegler ◽  
Christa Schimke ◽  
Peter Marchet ◽  
Birgit Stögermüller ◽  
Herbert Schöchl ◽  
...  

Vox Sanguinis ◽  
2000 ◽  
Vol 79 (3) ◽  
pp. 156-160 ◽  
Author(s):  
J.A. Aznar ◽  
S. Bonanad ◽  
J.M. Montoro ◽  
C. Hurtado ◽  
A.R. Cid ◽  
...  

2020 ◽  
pp. 49-60
Author(s):  
Ivan Krivov ◽  
Aligejdar Ragimov ◽  
Emin Salimov ◽  
Karim Magadeev ◽  
Yana Mishutkina

The article presents research data on the conservation of coagulation potential of lyophilized plasma inactivated by three different technologies — amotosalen and ultraviolet irradiation of spectrum A, riboflavin + ultraviolet of spectrum B, methylene blue + visible light. The study analyzed the concentration of blood-coagulation factors that affect the extrinsic, intrinsic and general coagulation pathways by comparing samples of virus-inactivated lyophilized plasma with various inactivation methods. As a result of the study, no significant differences in the indices between samples of plasma inactivated by various methods were detected. Therefore, virus-inactivated lyophilized plasma can serve as a full alternative to fresh frozen plasma.


Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 1412-1412
Author(s):  
Donald M. Arnold ◽  
Heather Whittingham ◽  
Francois Lauzier ◽  
France Clarke ◽  
Ellen McDonald ◽  
...  

Abstract Abstract 1412 Poster Board I-435 Introduction: The overuse of fresh frozen plasma (FFP) transfusions has been well documented, especially among critically ill patients. In a mixed medical surgical intensive care unit (ICU), we documented that 43% of FFP transfusions were given for indications other than those proposed in published guidelines (Lauzier 2007). Methods: We developed a 3-Phase multifaceted behavior-change strategy to curtail inappropriate FFP transfusions, documenting all patients who had FFP, excluding plasmapheresis. Phase I was a 3-month baseline assessment period with no intervention, in which the FFP transfusion orders prescribed at the discretion of the ICU team were recorded. Phase II was a 3-month intervention targeted to all ICU clinicians, comprised of education on the appropriate use of FFP transfusions, audit and feedback of performance indicators, and a pre-order FFP Request Form to specify the indication and the pre-transfusion INR. Phase III was a 9-month assessment period incorporating only the FFP Request Form. At the end of the study, the indications for all transfusions were adjudicated independently in triplicate by 2 ICU clinicians and 1 hematologist, to determine whether each FFP transfusion was a) consistent with published guidelines, b) inconsistent with guidelines but appropriate for the ICU context, or c) inconsistent and inappropriate. Discrepancies were resolved in all cases. FFP orders were not withheld if FFP Request Forms were not completed. Results: Chance-corrected agreement (which considers clustered transfusions within patients) between ICU reviewers on whether transfusions were consistent or appropriate versus inconsistent and inappropriate was high (phi = 0.80). During Phase I (3 months), 66 FFP transfusions were administered (n= 26 patients), of which 30 were for bleeding. During Phase II (3 months), 24 transfusions were administered (n = 11 patients), of which 11 were for bleeding. During Phase III (7 months of data), 96 transfusions were given (n= 41 patients), of which 57 were for bleeding. Rates of FFP transfusions per month for all indications and for bleeding indications were 22 and 10, respectfully in Phase I; 8 and 4 in Phase II; and 14 and 8 in Phase III. A FFP Request form accompanied 39 (40.6%) of 96 FFP transfusions in Phase III. Conclusions: A multifaceted behavior-change strategy appears to be an effective method of changing inappropriate FFP transfusion practices; however satisfactory uptake of a pre-transfusion FFP Request Form requires consistent reminders. We recommend that transfusion guidelines are improved to explicitly incorporate FFP transfusion criteria appropriate for the ICU setting. Disclosures: No relevant conflicts of interest to declare.


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