Phase I/II safety study of transfusion of prion-filtered red cell concentrates in transfusion-dependent patients.
Affiliation
Department of Haematology, Cork University Hospital, Cork, Ireland. maryr.cahill@hse.ieIssue Date
2010-08-01MeSH
AdultCreutzfeldt-Jakob Syndrome
Erythrocyte Transfusion
Erythrocytes
Hemofiltration
Humans
Prions
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Phase I/II safety study of transfusion of prion-filtered red cell concentrates in transfusion-dependent patients. 2010, 99 (2):174-6 Vox Sang.Journal
Vox sanguinisDOI
10.1111/j.1423-0410.2010.01330.xPubMed ID
20345513Abstract
Variant Creutzfeldt-Jakob (vCJD) is a fatal transfusion transmissible prion infection. No test for vCJD in the donor population is currently available. Therefore, prion removal by filtration of red cell concentrate (RCC) is an attractive option for prevention.Twenty patients were recruited with ethical permission, to receive clinically necessary transfusion containing one unit of pfRCC. Follow-up at 24 hours, 6 weeks and 6 months was undertaken. A second pfRCC was administered to 6 patients with similar follow up. pfRCC were prepared using the CE marked P-Capt device by the IBTS.
In 20 transfused patients undergoing one exposure to a prion filtered unit, no attributable adverse events were noted. A subset of these (n = 6) underwent re-exposure to a further filtered unit without incident.
This phase 1/11 clinical study provides encouraging data on safety of prion filtration which can be used to plan more extensive studies on the use of filtered blood in adults and children.
Item Type
ArticleLanguage
enISSN
1423-0410ae974a485f413a2113503eed53cd6c53
10.1111/j.1423-0410.2010.01330.x
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