Low risk of viral infection after administration of vapor‐heated factor VII concentrate or factor IX complex in first‐time recipients of blood components. International Factor Safety Study Group

Shapiro, Amy D.; Abe, Takaya; Aledort, Louis M.; Anderle, K; Hilgartner, Margaret W.; Kunschak, M; Preston, F. E.; Rivard, Georges E.; Schimpf, K.

doi:10.1046/j.1537-2995.1995.35395184275.x

Cited by 21 publications

(9 citation statements)

References 12 publications

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“…This concentrate has been used in other clinical studies (19) and is not licensed in Germany. The safety of the vapor heating process used for virus inactivation was demonstrated in an international study in which no cases of product-related transmission of hepatitis viruses or HIV occurred (20). Written informed consent was obtained from patients and/or parents before administration and permission for the clinical study was granted by the appropriate authorities.…”

Section: Plasminogen Concentratementioning

confidence: 99%

Human homozygous type I plasminogen deficiency and ligneous conjunctivitis

Mingers

Philapitsch

Zeitler

et al. 1999

APMIS

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Mingers A-M, Philapitsch A, Zeitler P, Schuster V, Schwarz HP & Kreth HW. Human homozygous type I plasminogen deficiency and ligneous conjunctivitis. APMIS 1999: 107:62-72.On the basis of a questionnaire sent to the ophthalmology departments of hospitals throughout Germany, 10 patients with ligneous conjunctivitis or pseudomembranous disease, ranging in age from 1 to 71 years were identified. All 10 patients had severely reduced plasminogen levels. Genetic analysis revealed homozygous type I plasminogen deficiency (which had not previously been described in humans) in 7 patients and compound heterozygous plasminogen deficiency in 1 patient. Clear differentiation was not possible in 2 patients. Most of the parents had heterozygous plasminogen deficiency. None of the patients had experienced any episodes of thrombosis. Additionally, the following observations were made: 1) Levels of polymorphonuclear (PMN)-elastase protein were markedly elevated in 6 of 6 patients and 10 of 1 1 parents tested, and levels were higher in homozygotes than in heterozygotes. 2) Hereditary factor XI1 deficiency was found in 3 of 6 patients tested. 3) CI-inhibitor was elevated in 2 of 4 patients, prekallikrein was elevated in 1 of 4 patients, and plasminogen activator inhibitor type 1 was elevated in 1 of 4 patients. Infusions of lys-plasminogen concentrate induced pronounced fibrinolytic activity as indicated by high levels of D-dimer, increases in plasmin-antiplasmin complex and decreases in polymorphonuclear elastase. C 1 -inhibitor, prekallikrein and PAI-1 normalized after repeated infusions of lys-plasminogen. In contrast to dysplasminogenemia, severe type I plasminogen deficiency might be seen as a problem of extravascular space, in particular of the mucous membranes, possibly triggered by mechanically induced or inflammatory lesions of the vessels supplying the tissue.We diagnosed homozygous type I plasminogen deficiency for the first time in 1994. This defect of the fibrinolytic system had not previously been seen in humans. The patient was an 18-month-old female infant who had ligneous conjunctivitis ( 1 4 ) as well as congenital hydrocephalus. Occlusions had repeatedly occurred at the tips of shunts inserted for drainage, but there was no other evidence of thrombus formation. The etiology of ligneous conjunctivitis was unclear at that time (5-17), and we hypothesized that it was related to the severe plasminogen deficiency. We therefore decided to study this condition in more detail.A questionnaire focusing on genetic aspects was

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Section: Plasminogen Concentratementioning

confidence: 99%

Human homozygous type I plasminogen deficiency and ligneous conjunctivitis

Mingers

Philapitsch

Zeitler

et al. 1999

APMIS

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“…This fibrin sealant (Tissucol®) was extracted from human plasma, processed to ensure its safety and traceability (selection of donors, quarantining of plasma, testing for viral contamination by Polymerase Chain Reaction, viral inactivation processes, measures with regard to bovine spongiform encephalopathy, specially for aprotinin from bovine origin). Before any processing, donors were screened during the plasma harvesting and 3 months after for human immunodeficiency virus, Epstein‐Barr virus, cytomegalovirus, and hepatitis A, B, and C 24…”

Section: Discussionmentioning

confidence: 99%

Fibrin sealant decreases postoperative drainage in immediate breast reconstruction by deep inferior epigastric perforator flap after mastectomy with axillary dissection

et al. 2010

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“…multimodal) of techniques. Vapour heating for 10 h has been reported to eectively eliminate infectivity of HAV [8], HBV, HCV and HIV, when analysed by log reduction factors and clinical follow-up [1,9]. Biesert et al have reported laboratory ®ndings which demonstrate the ecacy of a combination approach to decrease virus infectivity.…”

Section: Dry-heat Inactivation Of Concentrates At Temperatures Ofmentioning

confidence: 99%

Efficacy of viral clearance methods used in the manufacture of activated prothrombin complex concentrates: focus on AUTOPLEX® T

Horwith¹,

Revie²

1999

Haemophilia

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Various methods are described for the elimination of infectious viruses from activated prothrombin complex concentrates (aPCCs) and for the analysis of the final products (AUTOPLEX T and FEIBA VH). Viruses of concern in human plasma-derived products are enveloped (hepatitis B and C, cytomegalovirus, Epstein-Barr virus, and human immunodeficiency virus [HIV]) and nonenveloped (hepatitis A and parvovirus B19). Donated blood used for AUTOPLEX T is screened for antihepatitis C, HBsAg, anti-HIV types 1 and 2, and p24 antigen. Plasma pools utilized for raw materials are also tested by PCR for HIV and hepatitis C virus. Partial virus inactivation and partitioning are achieved by purification of the aPCC. Further reduction of virus infectivity is accomplished by lyophilization and dry-heat treatment. Each step undergoes virus elimination validation studies in which a relevant sample is 'spiked' with the appropriate virus or model virus. The total reduction in virus from raw material to final product can then be calculated. For AUTOPLEX T the cumulative log10 reduction factors for several viruses vary from 4.2 to 14.3. This ensures an exceptionally high margin of safety. Definitive evidence for product safety was obtained by clinical observation of treated patients. The viral inactivation process of AUTOPLEX T involves a four-tier viral safety program, including Cohn alcohol fractionation and dry-heat treatment, in place of the two-stage vapour-heating process for FEIBA.

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Low risk of viral infection after administration of vapor‐heated factor VII concentrate or factor IX complex in first‐time recipients of blood components. International Factor Safety Study Group

Abstract: Vapor-heated factor VII concentrate and vapor-heated factor IX complex are associated with a low risk of viral infection. Preliminary results are also presented, indicating that the concentrates are safe with regard to inhibitor development.

Cited by 21 publications

References 12 publications

Human homozygous type I plasminogen deficiency and ligneous conjunctivitis

Human homozygous type I plasminogen deficiency and ligneous conjunctivitis

Fibrin sealant decreases postoperative drainage in immediate breast reconstruction by deep inferior epigastric perforator flap after mastectomy with axillary dissection

Efficacy of viral clearance methods used in the manufacture of activated prothrombin complex concentrates: focus on AUTOPLEX® T

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