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lyophilized plasma fibrinogen

Steven Sanders, Homer Tien, Jeannie Callum, Barto Nascimento, Henry Peng, Chris Funk, Joanne Schmid, Sandro Rizoli, Shawn Rhind, Andrew Beckett
Introduction: Hemorrhage is the most common cause of death among Special Operations Force (SOF) soldiers. Bringing remote damage control resuscitation into the far-forward combat environment is logistically challenging, as it requires blood products that generally require a robust cold chain. Alternatively, lyophilized products such as fibrinogen concentrate, which does not require thawing or blood group compatibility testing before use, might be advantageous in damage control resuscitation in the battlefield...
January 1, 2018: Military Medicine
Petra M Schulz, Werner Gehringer, Sabine Nöhring, Sebastian Müller, Torben Schmidt, Stephanie Kekeiss-Schertler, Cristina Solomon, Katharina Pock, Jürgen Römisch
Fibryga® is a new lyophilized fibrinogen concentrate for intravenous use for the treatment of congenital fibrinogen deficiency. fibryga® is produced from pooled human plasma and the final product is characterized by high purity, integrity, and pathogen safety. Functional activity of fibrinogen was demonstrated by cross-linking studies and thromboelastometry; integrity of the fibrinogen molecule was demonstrated by size exclusion chromatography and the detection of only trace amounts of activation markers in the final product...
March 2018: Biologicals: Journal of the International Association of Biological Standardization
D Garrigue, A Godier, A Glacet, J Labreuche, E Kipnis, C Paris, A Duhamel, E Resch, A Bauters, F Machuron, P Renom, P Goldstein, B Tavernier, A Sailliol, S Susen
Essentials An immediate supply of plasma in case of trauma-induced coagulopathy is required. The Traucc trial compared French Lyophilised Plasma (FLyP) and Fresh Frozen Plasma (FFP). FLyP achieved higher fibrinogen concentrations compared with FFP. FLyP led to a more rapid coagulopathy improvement than FFP. SUMMARY: Background Guidelines recommend beginning hemostatic resuscitation immediately in trauma patients. We aimed to investigate if French lyophilized plasma (FLyP) was more effective than fresh frozen plasma (FFP) for the initial management of trauma-induced coagulopathy...
March 2018: Journal of Thrombosis and Haemostasis: JTH
Giacomo E Iapichino, Martin Ponschab, Janne Cadamuro, Susanne Süssner, Christian Gabriel, Benjamin Dieplinger, Margot Egger, Christoph J Schlimp, Soheyl Bahrami, Herbert Schöchl
BACKGROUND: During massive hemorrhage, it is recommended to transfuse red blood cells, platelet concentrate, and fresh-frozen plasma in a ratio close to 1:1:1. To avoid the thawing process of fresh frozen plasma, lyophilized plasma (LP) is increasingly used. Evidence is limited on the activity of coagulation factors in reconstituted blood using LP and concentrated LP versions. STUDY DESIGN AND METHODS: Whole blood from ten healthy volunteers was separated into red blood cell, fresh frozen plasma, and platelet concentrate units...
July 2017: Transfusion
M Van Blerk, E Bailleul, B Chatelain, A Demulder, K Devreese, J Douxfils, M Jacquemin, K Jochmans, F Mullier, W Wijns, B China, K Vernelen, M R Soumali
INTRODUCTION: The Belgian national External Quality Assessment Scheme performed a survey to assess the effect of the direct oral anticoagulant apixaban on the coagulation assays prothrombin time (PT), activated partial thromboplastin time (aPTT), fibrinogen and antithrombin as performed with a large number of reagent/instrument combinations. METHODS: Four lyophilized plasma samples spiked with apixaban (0, 41, 94 and 225 ng/mL) were sent to the 195 Belgian and Luxembourg clinical laboratories performing coagulation testing...
August 2017: International Journal of Laboratory Hematology
Kenichi A Tanaka, Michael Mazzeffi, Miroslav Durila
Prothrombin complex concentrate (PCC) is a term to describe pharmacological products that contain lyophilized, human plasma-derived vitamin K-dependent factors (F), FII, FVII, FIX, FX, and various amounts of proteins C and S. PCCs can be rapidly reconstituted in a small volume (20 ml for about 500 international units (IU)) at bedside and administered regardless of the patient's blood type. PCCs are categorized as 4-factor PCC if they contain therapeutic amounts of FVII, and 3-factor PCC when FVII content is low...
2014: Journal of Intensive Care
Betzabeth Pereira, Josmary Brazón
ETHNOPHARMACOLOGICAL RELEVANCE: Brownea grandiceps flowers are used in Venezuelan folk medicine as anti-hemorrhagic in women with heavy menstrual blood loss (menorrhagia). However, prior to this study, there were no scientific investigations to support this fact, because the aqueous extract from Brownea grandiceps flowers had not been previously evaluated neither phytochemically nor biologically. The objective of this work was to evaluate in vitro the effects of aqueous extract from Brownea grandiceps flowers on the coagulation system and fibrinolysis...
February 3, 2015: Journal of Ethnopharmacology
Christoph J Schlimp, Cristina Solomon, Marco Ranucci, Gerald Hochleitner, Heinz Redl, Herbert Schöchl
BACKGROUND: Viscoelastic tests such as functional fibrinogen polymerization assays (FFPAs) in thrombelastography (TEG®) or thromboelastometry (ROTEM®) measure clot elasticity under platelet inhibition. Incomplete platelet inhibition influences maximum clot firmness (MCF) of FFPAs. We compared the ability of existing and newly developed FFPAs to eliminate the platelet contribution to clot strength. METHODS: MCF of whole blood (WB), platelet-rich plasma (PRP), and platelet-poor plasma samples was recorded using a ROTEM device with different FFPAs, including the TEG functional fibrinogen test (FFTEG) and different ROTEM-based assays: the standard fib-tem reagent (FIBTEM), a lyophilized single-portion reagent fib-tem S (FIBTEM-S), a newly developed reagent FIBTEM PLUS, as well as FIBTEM or the standard extrinsic activation reagent ex-tem® (EXTEM) combined with 10-μg abciximab (FIBTEM-ABC/EXTEM-ABC)...
February 2014: Anesthesia and Analgesia
Tim H Lee, Kate Watson, Loïc Fabricant, Jeffrey Barton, Jerome Differding, Igor Kremenevskiy, Claire Sands, Connor Wiles, Jennifer M Watters, Martin A Schreiber
BACKGROUND: We performed this study to optimize reconstituted lyophilized plasma (LP) into a minimal volume fluid that provides effective hemostatic resuscitation for trauma while minimizing logistical limitations. METHODS: We performed a prospective, blinded animal study. Plasma was lyophilized following whole blood collection from anesthetized swine. The minimal volume needed for reconstitution was determined, and this solution was evaluated for safe infusion into the swine...
September 2013: Journal of Trauma and Acute Care Surgery
Kenichi A Tanaka, Katherine Egan, Fania Szlam, Satoru Ogawa, John D Roback, Gautam Sreeram, Robert A Guyton, Edward P Chen
BACKGROUND: Platelet (PLT) and plasma transfusion remain the mainstay hemostatic therapy for perioperative bleeding. Several studies have indicated that acquired fibrinogen (FIB) deficiency can be the primary cause of bleeding after cardiac surgery. The aim of this study was to compare hematologic and transfusion profiles between the first-line FIB replacement and PLT transfusion in post-cardiac surgical bleeding. STUDY DESIGN AND METHODS: In this prospective, randomized, open-label study, 20 adult patients who underwent valve replacement or repair and fulfilled preset visual bleeding scale were randomized to 4 g of FIB or 1 unit of apheresis PLTs...
January 2014: Transfusion
Jürgen Bux, Dieter Dickhörner, Edgar Scheel
BACKGROUND: Transfusion of plasma is a basic treatment for complex coagulopathies as well as in major blood loss. Early transfusion of plasma after trauma with major hemorrhage has been recommended by retrospective studies. However, the use of plasma is often hampered by the need to maintain a cold chain and the time needed for thawing fresh-frozen plasma (FFP). With freeze-dried (lyophilized) plasma (FDP) both difficulties can be avoided. Here, we describe the production, quality characteristics, and our experiences with FDP...
December 2013: Transfusion
Ying Zheng, Feng-Ping Ye, Jie Wang, Guo-Yang Liao, Yun Zhang, Quan-Shui Fan, Wen-Hui Lee
A serine protease termed Da-36 was isolated from crude venom of Deinagkistrodon acutus. The enzyme was a single chain protein with an apparent molecular weight of 36,000 on SDS-PAGE with an isoelectric point of 6.59. Da-36 could clot human plasma by cleaving the Aα, Bβ and γ chains of fibrinogen and also exhibited arginine esterase activity. The proteolytic activity of Da-36 toward TAME was strongly inhibited by PMSF and moderately affected by benzamidine and aprotinin, indicating that it was a serine protease...
June 1, 2013: Toxicon: Official Journal of the International Society on Toxinology
Herbert Schöchl, Christoph J Schlimp, Wolfgang Voelckel
PURPOSE OF REVIEW: Diagnosis and treatment of trauma-induced coagulopathy (TIC) presents a challenge for trauma care providers. Viscoelastic tests (VETs) including thromboelastometry and thrombelastography are increasingly used to diagnose TIC and guide hemostatic therapy. We summarize the concept of individualized, goal-directed coagulation management using coagulation factor concentrates. RECENT FINDINGS: Early and aggressive treatment is mandatory to improve the survival of severely bleeding trauma patients...
April 2013: Current Opinion in Anaesthesiology
Jerrold H Levy, Fania Szlam, Kenichi A Tanaka, Roman M Sniecienski
Fibrinogen plays several key roles in the maintenance of hemostasis. Its cleavage by thrombin and subsequent polymerization to form fibrin strands provides the structural network required for effective clot formation. During cases of acute blood loss, attempts to maintain circulating volume and tissue perfusion often involve the infusion of crystalloids, colloids, and red blood cells. Intravascular volume resuscitation, although vital, frequently results in dilution of the remaining clotting factors and onset of dilutional coagulopathy...
February 2012: Anesthesia and Analgesia
Fahad Shuja, Robert A Finkelstein, Eugene Fukudome, Michael Duggan, Tareq Kheirbek, Kristopher Hamwi, Thomas H Fischer, Karim Fikry, Marc deMoya, George C Velmahos, Hasan B Alam
BACKGROUND: Trauma-associated coagulopathy carries an extremely high mortality. Fresh-frozen plasma (FFP) is the mainstay of treatment; however, its availability in the battlefield is limited. We have already shown that lyophilized, freeze-dried plasma (FDP) reconstituted in its original volume can reverse trauma-associated coagulopathy. To enhance the logistical advantage (lower volume and weight), we developed and tested a hyperoncotic, hyperosmotic spray-dried plasma (SDP) product in a multiple injuries/hemorrhagic shock swine model...
March 2011: Journal of Trauma
A P Piryazev, A V Aseichev, O A Azizova
Turbidimetry studies showed that after addition of thrombin to fresh donor plasma light scatter in the sample increases and slowly attains a plateau. The process of fibrin formation was less intensive in the presence of oxidized fibrinogen. The formation of fibrin clot in lyophilized plasma was characterized by a biphasic kinetic of light scatter, oxidized fibrinogen inhibited both phases of the process. In the presence of streptokinase, oxidized fibrinogen did not modify the kinetics of fibrin clot lysis. Addition of oxidized fibrinogen to plasma reduced optical density of fibrin clot the more intensely the higher was the degree of oxidative modification of fibrinogen...
December 2009: Bulletin of Experimental Biology and Medicine
A Dick, M Schwaiger, C Jámbor
Thromboelastography/thromboelastometry (TEG/ROTEM) is widely used in near-patient setting, especially in perioperative and intensive care medicine for the management of acute bleeding. Until now a comprehensive quality management especially an external quality control of TEG/ROTEM results is not established. Here we report about our results of a pilot survey performed in 2008 and 2009 integrated in the External Quality Assessment Schemes (EQAS) performed by INSTAND. According to this first EQAS data ROTEM results can be controlled in external quality schemes using lyophilized plasma samples...
May 2010: Hämostaseologie
Flora Peyvandi
Rare bleeding disorders represent 3-5% of all inherited coagulation factor disorders. Inherited afibrinogenemia, which is caused by a deficiency in plasma fibrinogen (coagulation factor I), accounts for only a small portion of all the rare bleeding disorders. Patients with afibrinogenemia have a variable bleeding pattern that may include potentially serious or life-threatening haemorrhages. Treatment of afibrinogenemia is aimed at replacing the missing fibrinogen to restore efficient haemostasis and to stop bleeding...
December 2009: Thrombosis Research
Fahad Shuja, Christian Shults, Michael Duggan, Malek Tabbara, Muhammad U Butt, Thomas H Fischer, Martin A Schreiber, Brandon Tieu, John B Holcomb, Jill L Sondeen, Marc Demoya, George C Velmahos, Hasan B Alam
BACKGROUND: Trauma-induced coagulopathy is associated with an extremely high mortality. We have recently shown that survival can be improved by correction of coagulopathy through early, aggressive infusion of Fresh Frozen Plasma (FFP). However, FFP is a perishable product, and its use is impractical in challenging environments such as a battlefield. Development of shelf-stable, easy to use, low volume, lyophilized, Freeze-Dried Plasma (FDP) can overcome the logistical limitations. We hereby report the development and testing of such a product...
November 2008: Journal of Trauma
Masahiro Okuda, Yahiro Uemura, Noriyuki Tatsumi
Plasma fibrinogen measurement is a routine laboratory procedure commonly performed on automated coagulation analysers. Its determination is quantitative, not quantitative. Yet, a lack of precision has been an issue for fibrinogen measurement. A control material derived from plasma comprises many proteins, inhibitors and fatty acids, any or all of which can interfere in the fibrinogen assay. This study has attempted to develop a quality control material using purified human fibrinogen and has compared measurement precision between both purified and plasma materials...
2003: Journal of Automated Methods & Management in Chemistry
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