scholarly journals Solvent/detergent-treated plasma: a virus-inactivated substitute for fresh frozen plasma

Blood ◽  
1992 ◽  
Vol 79 (3) ◽  
pp. 826-831 ◽  
Author(s):  
B Horowitz ◽  
R Bonomo ◽  
AM Prince ◽  
SN Chin ◽  
B Brotman ◽  
...  

Fresh frozen plasma (FFP) is prepared in blood banks world-wide as a by- product of red blood cell concentrate preparation. Appropriate clinical use is for coagulation factor disorders where appropriate concentrates are unavailable and when multiple coagulation factor deficits occur such as in surgery. Viral safety depends on donor selection and screening; thus, there continues to be a small but defined risk of viral transmission comparable with that exhibited by whole blood. We have prepared a virus sterilized FFP (S/D-FFP) by treatment of FFP with 1% tri(n-butyl)phosphate (TNBP) and 1% Triton X-100 at 30 degrees C for 4 hours. Added reagents are removed by extraction with soybean oil and chromatography on insolubilized C18 resin. Treatment results in the rapid and complete inactivation of greater than or equal to 10(7.5) infectious doses (ID50) of vesicular stomatitis virus (VSV) and greater than or equal to 10(6.9) ID50 of sindbis virus (used as marker viruses), greater than or equal to 10(6.2) ID50 of human immunodeficiency virus (HIV), greater than or equal to 10(6) chimp infectious doses (CID50) of hepatitis B virus (HBV), and greater than or equal to 10(5) CID50 of hepatitis C virus (HCV). Immunization of rabbits with S/D-FFP and subsequent adsorption of elicited antibodies with untreated FFP confirmed the absence of neoimmungen formation. Coagulation factor content was comparable with that found in FFP. Based on these laboratory and animal studies, together with the extensive history of the successful use of S/D-treated coagulation factor concentrates, we conclude that replacement of FFP with S/D-FFP, prepared in a manufacturing facility, will result in improved virus safety and product uniformity with no loss of efficacy.

Blood ◽  
1992 ◽  
Vol 79 (3) ◽  
pp. 826-831 ◽  
Author(s):  
B Horowitz ◽  
R Bonomo ◽  
AM Prince ◽  
SN Chin ◽  
B Brotman ◽  
...  

Abstract Fresh frozen plasma (FFP) is prepared in blood banks world-wide as a by- product of red blood cell concentrate preparation. Appropriate clinical use is for coagulation factor disorders where appropriate concentrates are unavailable and when multiple coagulation factor deficits occur such as in surgery. Viral safety depends on donor selection and screening; thus, there continues to be a small but defined risk of viral transmission comparable with that exhibited by whole blood. We have prepared a virus sterilized FFP (S/D-FFP) by treatment of FFP with 1% tri(n-butyl)phosphate (TNBP) and 1% Triton X-100 at 30 degrees C for 4 hours. Added reagents are removed by extraction with soybean oil and chromatography on insolubilized C18 resin. Treatment results in the rapid and complete inactivation of greater than or equal to 10(7.5) infectious doses (ID50) of vesicular stomatitis virus (VSV) and greater than or equal to 10(6.9) ID50 of sindbis virus (used as marker viruses), greater than or equal to 10(6.2) ID50 of human immunodeficiency virus (HIV), greater than or equal to 10(6) chimp infectious doses (CID50) of hepatitis B virus (HBV), and greater than or equal to 10(5) CID50 of hepatitis C virus (HCV). Immunization of rabbits with S/D-FFP and subsequent adsorption of elicited antibodies with untreated FFP confirmed the absence of neoimmungen formation. Coagulation factor content was comparable with that found in FFP. Based on these laboratory and animal studies, together with the extensive history of the successful use of S/D-treated coagulation factor concentrates, we conclude that replacement of FFP with S/D-FFP, prepared in a manufacturing facility, will result in improved virus safety and product uniformity with no loss of efficacy.


Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 4204-4204
Author(s):  
Fleur M Aung

Abstract 4204 A 58 year old male with a known clinical history of Passovoy defect was evaluated for a craniotomy for an olfactory meningioma. His family history revealed that this defect was present in multiple family members (siblings, parent and child). In the past, he had had several successful and several complicated surgeries. According to his past history, bleeding did not occur intra-operatively but typically 24-72 hours post-operatively. There was no evidence of mucosal bleeding, petechiae, rashes or ecchymosis on examination. There was no past history of spontaneous hemorrhage, epistaxis, hemoptysis, hematemesis, melena, petechiae or ecchymosis. Past surgical history revealed that when bleeding occurred and FFP was transfused post-operatively, the bleeding subsided. When Fresh Frozen Plasma (FFP) was transfused pre-operatively, intra-operatively and post-operatively there was no significant bleeding. Laboratory tests showed normal ProthrombinTime (PT), activated Partial Thromboplastin Time (aPTT), ThrombinTime (TT), Fibrinogen, Factor VIII and Factor XIII, vWFAntigen and vWF multimers. Platelet Aggregation studies were normal except for a decreased response to epinephrine. Thromboelastogram studies revealed a mild coagulation factor deficiency. Our workup did not show any of the common coagulation defects. There was no evidence of a prolonged Partial Thromboplastin Time (aPTT) as reported in the literature. Due to normal aPTT results (average 27.7 secs, range 25.5– 38.1 secs), mixing studies were not performed. Due to his significant past clinical history, the patient was transfused with Fresh Frozen Plasma (FFP) pre-operatively, intra-operatively and post- operatively for 72 hrs. The PT/aPTT and platelet counts remained within normal range throughout the patient's entire hospital stay with no evidence of bleeding post-operatively. Passovoy Defect is a rare autosomal disorder and is a coagulation abnormality affecting the intrinsic coagulation system characterized by a prolonged aPTT. The defect is associated with a clinical bleeding tendency characterized by easy bruising and undue blood loss following trauma and/or surgery. Fresh Frozen Plasma appears to provide effective prophylaxis during surgery. The bleeding phenotype is variable. There may be no bleeding after major surgeries. Major bleeding after minor surgeries is not uncommon. Our case represents a rare type of a defect in the intrinsic system that may not be encountered in the daily setting with a normal active Partial Thromboplastic Time (aPTT). The Passovoy Defect in our patient appears to be transmitted as an autosomal dominant trait. Despite a very significant clinical and family history, the aPTT was within normal range throughout his hospitaization. No diagnostic laboratory findings were noted. It has been reported that the prolongation of aPTT in some of the patients may be relatively mild. However this was not the case in our patient. We do not know whether our patient has a deficiency of an unknown coagulation factor or that our aPTT reagent (HemosIL SynthASIL Catalogue # 20006800, DiaPharma Group Inc, West Chester, OH, USA) was not sensitive to the Passovoy Defect. Disclosures: No relevant conflicts of interest to declare.


Author(s):  
Hortensia De la Corte-Rodriguez ◽  
E. Carlos Rodriguez-Merchan ◽  
M. Teresa Alvarez-Roman ◽  
Monica Martin-Salces ◽  
Victor Jimenez-Yuste

Background: It is important to discard those practices that do not add value. As a result, several initiatives have emerged. All of them try to improve patient safety and the use of health resources. Purpose: To present a compendium of "do not do recommendations" in the context of hemophilia. Methods: A review of the literature and current clinical guidelines has been made, based on the best evidence available to date. Results: The following 13 recommendations stand out: 1) Do not delay the administration of factor after trauma; 2) do not use fresh frozen plasma or cryoprecipitate; 3) do not use desmopressin in case of hematuria; 4) do not change the product in the first 50 prophylaxis exposures; 5) do not interrupt immunotolerance; 6) do not administer aspirin or NSAIDs; 7) do not administer intramuscular injections; 8) do not do routine radiographs of the joint in case of acute hemarthrosis; 9) Do not apply closed casts for fractures; 10) do not discourage the performance of physical activities; 11) do not deny surgery to a patient with an inhibitor; 12) do not perform instrumental deliveries in fetuses with hemophilia; 13) do not use factor IX (FIX) in patients with hemophilia B with inhibitor and a history of anaphylaxis after administration of FIX. Conclusions: The information mentioned previously can be useful in the management of hemophilia, from different levels of care. As far as we know, this is the first initiative of this type regarding hemophilia.


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.


2006 ◽  
Vol 21 (4) ◽  
pp. 224-226 ◽  
Author(s):  
Rameshwar S. Sidhu ◽  
Tuan Le ◽  
Brad Brimhall ◽  
Hannis Thompson

Transfusion ◽  
2005 ◽  
Vol 45 (8) ◽  
pp. 1362-1372 ◽  
Author(s):  
Pedro De Alarcon ◽  
Richard Benjamin ◽  
Marion Dugdale ◽  
Craig Kessler ◽  
Rinah Shopnick ◽  
...  

2013 ◽  
Vol 119 (4) ◽  
pp. 1050-1057 ◽  
Author(s):  
Marie Roguski ◽  
Kyle Wu ◽  
Ron I. Riesenburger ◽  
Julian K. Wu

Object A primary goal in the treatment of patients with warfarin-associated subdural hematoma (SDH) is reversal of coagulopathy with fresh-frozen plasma. Achieving the traditional target international normalized ratio (INR) of 1.3 is often difficult and may expose patients to risks of volume overload and of thromboembolic complications. This retrospective study evaluates the risk of mild elevations of INR from 1.31 to 1.69 at 24 hours after admission in patients presenting with warfarin-associated SDH. Methods Sixty-nine patients with warfarin-associated SDH and 197 patients with non–warfarin-associated SDH treated at a single institution between January 2005 and January 2012 were retrospectively identified. Charts were reviewed for patient age, history of trauma, associated injuries, neurological status at presentation, size and chronicity of SDH, associated midline shift, INR at admission and at hospital Day 1 (HD1), concomitant aspirin or Plavix use, platelet count, and medical comorbidities. Patients were stratified according to use of warfarin and by INR at HD1 (INR 0.8–1.3, 1.31–1.69, 1.7–1.99, and ≥ 2). The groups were evaluated for differences the in rate of radiographic expansion of SDH and in the rate of clinically significant SDH expansion resulting in death, unplanned procedure, and/or readmission. Results There was no difference in the rate of radiographic versus clinically significant expansion of SDH between patients not on warfarin and those on warfarin (no warfarin: 22.3% vs 20.3%, p = 0.866; warfarin: 10.7% vs 11.6%, p = 0.825), but the rate of medical complications was significantly higher in the warfarin subgroup (13.3% for patients who did not receive warfarin vs 26.1% for those who did; p = 0.023). For warfarin-associated SDH, there was no difference in the rate of radiographic versus clinically significant expansion between patients reversed to HD1 INRs of 0.8–1.3 and 1.31–1.69 (HD1 INR 0.8–1.3: 22.5% vs 20%, p = 1; HD1 INR 1.31–1.69: 15% vs 10%, p = 0.71). Conclusions Mild INR elevations of 1.31–1.69 in warfarin-associated SDH are not associated with a markedly increased risk of radiographic or clinically significant expansion of SDH. Larger prospective studies are needed to determine if subtherapeutic INR elevations at HD1 are associated with smaller increases in risk of SDH expansion.


2021 ◽  
Author(s):  
João Vitor Ribeiro dos Santos ◽  
Mariana Spitz ◽  
Ana Carolina Andorinho

Introduction: Thrombotic thrombocytopenic purpura (TTP) is a hematological disease resulting from the ADAMTS 13 plasmatic protein deficit. It can be congenital or sporadic, and is usually autoimmune. Pathological platelet adhesion occurs, leading to microthrombi in capillary and arterial circulation, microangiopathic anemia and ischemia. The clinical picture includes thrombocytopenia, renal dysfunction, fluctuating neurological symptoms, microangiopathic hemolytic anemia, and fever. Methods: Case report of a 51-year-old male hypertensive patient, diagnosed with idiopathic thrombocytopenic purpura (ITP) 10 years ago and submitted to splenectomy 5 years ago, who developed acute cholecystitis. He underwent urgent colecistectomy, and on the fourth postoperative day presented sudden space and time disorientation, transcortical motor aphasia and right faciobrachial paresis, with ipsilateral Babinski and Hoffman signs. Results: Brain CT showed left frontoparietal hypodensity. During hospitalization, there was worsening of renal function, increased LDH, and thrombocytopenia. Hematoscopy identified signs of intravascular hemolysis (erythrocyte fragmentation, reticulocytosis, helmet erythrocytes). Direct Coombs was negative. There was no history of heparin use. TTP was diagnosed, and fresh frozen plasma and prednisone 1mg/kg were prescribed. There was resolution of thrombotic microangiopathy, with subsequent increase of platelet levels, decreased LDH and improved hematoscopy. Conclusions: This case illustrates a rare cause of stroke and an unusual association of two hematological conditions: ITP and TTP. The treatment of TTP consists of replacement of deficient ADAMTS13 protein through plasmapheresis or fresh frozen plasma. The use of immunosuppressants is also associated, initially with glucocorticoids, followed by rituximab or splenectomy in order to prevent recurrences.


2019 ◽  
Vol 2019 ◽  
pp. 1-3 ◽  
Author(s):  
Osamah Hasan ◽  
Ankit A. Patel ◽  
James J. Siegert

Recreational use of synthetic cannabinoids (SCs), also known as “K2” or “Spice,” is becoming a major public-health concern due to their potential for abuse and harmful consequences. New substances are constantly being added to the content of SCs. The dearth of information on these newly added contents as they are introduced into the black market hinders risk assessments of these compounds. We report a highly unusual case of gross hematuria in a 28-year-old male patient after SC use. He was found to have a supratherapeutic INR with no history of prior anticoagulation. His hematuria resolved after four units of fresh-frozen plasma were administered. We include a literature review of the clinical effects of SCs and their possible mechanism of gross hematuria and management.


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