| Pathogen Inactivation of Platelet and Plasma Blood Components for Transfusion Using the INTERCEPT Blood System™ | |
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MedLine Citation:
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PMID: 21779203 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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BACKGROUND: The transmission of pathogens via blood transfusion is still a major threat. Expert conferences established the need for a pro-active approach and concluded that the introduction of a pathogen inactivation/reduction technology requires a thorough safety profile, a comprehensive pre-clinical and clinical development and an ongoing hemovigilance program. MATERIAL AND METHODS: The INTERCEPT Blood System utilizes amotosalen and UVA light and enables for the treatment of platelets and plasma in the same device. Preclinical studies of pathogen inactivation and toxicology and a thorough program of clinical studies have been conducted and an active he-movigilance-program established. RESULTS: INTERCEPT shows robust efficacy of inactivation for viruses, bacteria (including spirochetes), protozoa and leukocytes as well as large safety margins. Furthermore, it integrates well into routine blood center operations. The clinical study program demonstrates the successful use for very diverse patient groups. The hemovigilance program shows safety and tolerability in routine use. Approximately 700,000 INTERCEPT-treated products have been transfused worldwide. The system is in clinical use since class III CE-mark registration in 2002. The safety and efficacy has been shown in routine use and during an epidemic. CONCLUSION: The INTERCEPT Blood System for platelets and plasma offers enhanced safety for the patient and protection against transfusion-transmitted infections. |
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Authors:
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Johannes Irsch; Lily Lin |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2011-1-27 |
Journal Detail:
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Title: Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie Volume: 38 ISSN: 1660-3818 ISO Abbreviation: - Publication Date: 2011 |
Date Detail:
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Created Date: 2011-7-22 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101176417 Medline TA: Transfus Med Hemother Country: - |
Other Details:
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Languages: ENG Pagination: 19-31 Citation Subset: - |
Affiliation:
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Cerus Europe BV, Amersfoort, the Netherlands. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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