Efficacy evaluation of current and future platelet transfusion products
Efficacy evaluation of current and future platelet transfusion products
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DOI：
10.1097/01.ta.0000199921.40502.5d
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发表时间：
2006-06-01
影响因子：
--
通讯作者：
Vostal, JG
中科院分区：
文献类型：
--
作者：
Vostal, JG
This practice is based on clinical experience which has shown that thrombocytopenic patients have a tendency to bleed spontaneously while patients whose platelet counts have been raised by platelet transfusions have decreased frequency of such events. 1 Clinicians have a high level of certainty that the platelets they transfuse will be safe and effective in preventing and stopping bleeding because the platelet products have been collected from healthy donors using either licensed apheresis instruments or through routine whole blood collections, and stored in licensed storage containers according to manufacturers’ instructions. A general definition of platelet efficacy is the ability of the platelet to remain in circulation and to participate in hemostasis. If a product is collected or stored by a method that differs from proven and established methodologies the level of certainty about the performance would decrease based on the size and nature of the deviation from established collection and processing methods. A collection process that is drastically different would raise doubt about the efficacy of the platelets collected by it.The review of platelet products by the FDA2 consists of the following scheme: Platelets prepared by slight variations of established methodologies would raise issues of safety and efficacy to a lesser degree than would a novel, chemically treated, pathogen-reduced platelet product. The level of scrutiny of a platelet product is tied to the level of concern about platelet damage that may have occurred during collection and processing (Fig. 1). For minimal levels of concern in vitro tests of platelet function are usually sufficient. The in vitro tests evaluate various aspects of platelet physiology, morphology and biochemistry. The tests include quantitation of discoid shapes and aberrant forms of platelets, responses to agonists and measurement of metabolic indicators such as
