octaplas

OBJECTIVE: To examine the effect of blood products on the occurrence of stroke after coronary artery surgery. DESIGN: Institutional retrospective analysis. SETTING: University hospital. PARTICIPANTS: One thousand three hundred fourteen patients undergoing coronary artery surgery. INTERVENTIONS: Off-pump coronary artery bypass grafting (OPCAB). Epiaortic ultrasound was performed in all patients...

In recent Coimbra' Conference, on the pre-launch of pathogen reduced-FFP for the local clinical use, the question was raised, by the moderator, on the efficacy of the current methodology used for prion removal processes and its influence on the overall quality and safety of the final product. This brief paper put together by speaker of this session and the moderator, as a consensus of opinions, which was largely discussed during Q&A session, to make it available to a large group of readers of transfusion apheresis science, who might be interested to this topic...

This study assessed the cost-effectiveness of Octaplas™ versus fresh frozen plasma (FFP) in patients receiving plasma transfusions in the United States (US). Acute and long-term complications of plasma transfusions were modelled in a decision tree followed by a Markov model, using a healthcare payer perspective. Over a lifetime time horizon, patients receiving Octaplas™ accumulate slightly more life years (0.00613 [95% uncertainty interval (95%UI): 0.00166-0.01561]) and quality-adjusted life years (QALY) (0...

BACKGROUND: Liver transplantation regularly requires transfusion of red blood cells (RBCs), plasma, and platelets. Compared to fresh frozen plasma (FFP) from single blood donors, solvent/detergent-treated plasma (SD-plasma) pooled from several hundred blood donors has advantages with respect to pathogen reduction, standardized content of plasma proteins, and significantly reduced risk of transfusion related lung injury and allergic/immunologic adverse reactions. However, SD-plasma has been suspected to increase the incidence of hyperfibrinolysis and thromboembolic events...

BACKGROUND: Thromboelastography (TEG) is widely used in hospitals but less commonly in blood banks for evaluation of platelet (PLT) concentrates (PCs). A TEG-PC assay for testing fresh or stored PLTs must reflect the quality of the PLTs. The added value could be measurement of donor-dependent PLT quality. STUDY DESIGN AND METHODS: Whole blood (WB) normal values were generated from 100 donors, using standard tests. Nineteen single-donor PCs were evaluated with a TEG-PC assay, using Octaplas as microparticle-free diluent and kaolin or collagen as activator, stored up to 12 days, and also sampled for additional in vitro tests...

BACKGROUND: The aim of this study was to investigate the impact of transfusion of blood products on intermediate outcome after coronary artery bypass surgery. PATIENTS: Complete data on perioperative blood transfusion in patients undergoing coronary artery bypass surgery were available from 2001 patients who were operated at our institution. RESULTS: Transfusion of any blood product (relative risk = 1.678, 95% confidence interval = 1.087-2...

BACKGROUND: Viscoelastic tests such as functional fibrinogen polymerization assays (FFPAs) in thrombelastography (TEG(®)) or thromboelastometry (ROTEM(®)) measure the elasticity of extrinsically activated clotting under conditions of platelet inhibition. There are no reports on whether components of the FFPAs have any effects on fibrin polymerization, aside from the effects of platelet inhibition. METHODS: Using various platelet-free plasma (PFP) preparations, we compared the extrinsically activated EXTEM thromboelastometric assay with 3 FFPAs: FIBTEM, FIBTEM PLUS, and the Functional Fibrinogen Test(®) (FFTEG)...

BACKGROUND: Pooling of plasma of different blood groups before large scale manufacturing of Uniplas(®) results in the formation of low levels of soluble immune complexes (CIC). The aim of this study was to investigate the level and removal of CIC during Uniplas(®) manufacturing. In addition, an in vitro hemolysis assay should be developed and investigate if Uniplas(®) does induce complement-mediated hemolysis of human red blood cells (RBC). MATERIALS AND METHODS: In-process samples from Uniplas(®) (universal plasma) and Octaplas(LG)(®) (blood group specific plasma) routine manufacturing batches were tested on CIC using commercially available ELISA test kits...

Bedaquiline for multiresistant pulmonary tuberculosis; Flublok influenza vaccine; and Octaplas for coagulation factor deficiency.

BACKGROUND: Octaplas LG is a prion-depleted version of a previous generation product called Octaplas S/D. We compared the recovery, safety, and tolerability of these two pharmaceutical-grade plasmas. STUDY DESIGN AND METHODS: In this comparative, block-randomized, open-label, active-controlled, crossover Phase I trial, 60 healthy adult volunteers received single transfusions of 1200 mL of parent product (in Period 1) and of the LG plasma product (in Period 2) or vice versa...

BACKGROUND: Fibrinogen replacement is critical in major obstetric haemorrhage (MOH). Purified, pasteurised fibrinogen concentrate appears to have benefit over cryoprecipitate in ease of administration and safety but is unlicensed in pregnancy. In July 2009, the Irish Blood Transfusion Service replaced cryoprecipitate with fibrinogen. OBJECTIVES: To examine the impact of this externally imposed change on blood product use and clinical outcomes in MOH. METHODS: Women with MOH requiring fibrinogen between 1 January 2009 and 30 June 2011 were identified from an MOH database...

No abstract text is available yet for this article.

BACKGROUND: The impact of blood transfusion on the development of post-operative stroke after coronary artery bypass grafting (CABG) is not well established. We, therefore, investigated this issue. MATERIALS AND METHODS: Complete data on peri-operative blood transfusion were available for 2,226 patients who underwent CABG in three Finnish hospitals. RESULTS: Stroke occurred post-operatively in 53 patients (2.4%). Logistic regression showed that pre-operative creatinine (OR 1...

INTRODUCTION: Octaplas® LG is a second-generation solvent/detergent-treated plasma that offers an additional safety benefit by prion elimination. The stability of clotting factors of the new S/D plasma after thawing has not been investigated yet. This study intended to measure the time course of fibrinogen, FII, FV, FVII, FVIII, FIX, PC, fPS and PI through storage at 2-6°C over 6 days. MATERIALS AND METHODS: We investigated 20 plasma bags (five bags per blood group) and measured fibrinogen, FII, FV, FVII, FVIII, FIX, PC, fPS and PI immediately after thawing and after 2, 4, 6, 24, 48, 72, 96, 120 and 144 h storage at 2-6°C...

The Irish Blood Transfusion Service is currently assessing the feasibility and affordability of implementing pathogen reduction for platelets in Ireland. Since 2002, almost all plasma transfused in the country has been subjected to a pathogen reduction process in the form of Octaplas™ (or Uniplas™ for group AB recipients), manufactured from plasma from donors at the South Texas Blood and Tissue Center, San Antonio, TX, USA. Pathogen reduction of platelets for Ireland is driven by two major concerns: by the need for robust systems to prevent the transmission of any emerging transfusion transmissible infections or of diseases for which we do not currently test, and by the poor sensitivity and efficacy of even the most sensitive available approaches to bacterial contamination of platelets...

BACKGROUND: Universal plasma is intended to be transfused irrespective of the blood group. We compared the safety and tolerability of a novel, universal blood group-independent plasma with an ABO-matched plasma. STUDY DESIGN AND METHODS: In this randomized, double-blind, active-controlled, crossover, Phase I trial, 30 healthy adult volunteers (blood group A, B, or AB) were randomly assigned to transfusion of 1200 mL of Uniplas LG and 1200 mL of Octaplas LG (both Octapharma AG) or vice versa...

BACKGROUND: Octapharma PPGmbH has recently modified its manufacturing process for solvent/detergent-treated plasma to incorporate a prion reduction step, in which a 3 log reduction has been demonstrated. The current study was undertaken to assess the impact of this procedure on haemostatic variables in the new product OctaplasLG in comparison with standard Octaplas. METHODS: Production batches of standard Octaplas (n=4) and OctaplasLG (n=16) were assessed for levels of coagulation factors, physiological protease inhibitors, markers of activation and procoagulant microparticles...

BACKGROUND AND OBJECTIVES: A new chromatographic step for the selective binding of abnormal prion protein (PrP(Sc)) was developed, and optimization for PrP(Sc) capture was achieved by binding to an affinity ligand attached to synthetic resin particles. This step was implemented into the manufacturing process of the solvent/detergent (S/D)-treated biopharmaceutical quality plasma Octaplas to further improve the safety margin in terms of risk for variant Creutzfeldt-Jakob disease (vCJD) transmission...

BACKGROUND AND OBJECTIVES: A new chromatographic step for the selective binding of pathological prion proteins (PrP(Sc)) to an affinity ligand, developed and optimized for PrP(Sc) capture and attached to synthetic resin particles (PRDT, USA; ProMetic BioSciences Ltd, Isle of Man, UK) was implemented into the manufacturing process of the solvent/detergent (S/D) treated biopharmaceutical quality plasma Octaplas. MATERIALS AND METHODS: Pilot batches of Octaplas with the implemented chromatographic step [labelled as OctaplasLG (ligand gel)] were manufactured by Octapharma PPGmbH, Vienna, Austria...

BACKGROUND AND OBJECTIVES: The most common way to thaw frozen coagulation-active plasma products for transfusion is the use of a water bath with good circulation at 30-37 degrees C. The aim of this study was to perform an extensive biochemical characterization of the pharmaceutically licenced solvent/detergent-treated plasma, Octaplas, thawed using the SAHARA-III dry tempering system from the company Sarstedt GmbH, Austria. A regular water bath was used in parallel for comparison. MATERIALS AND METHODS: Six batches Octaplas with different blood groups were thawed in a water bath or using the SAHARA-III dry tempering system in parallel...