Change search
ReferencesLink to record
Permanent link

Direct link
A prospective, active haemovigilance study with combined cohort analysis of 19 175 transfusions of platelet components prepared with amotosalen-UVA photochemical treatment
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Immunology, Genetics and Pathology.
Catholic Univ Louvain, Clin Univ Mont Godinne, Yvoir, Belgium..
Univ Roma La Sapienza, Dept Expt Med, I-00185 Rome, Italy..
Hosp Clin Barcelona, IDIBAPS, CDB, Dept Hemotherapy & Hemostasis, Barcelona, Spain..
Show others and affiliations
2015 (English)In: Vox Sanguinis, ISSN 0042-9007, E-ISSN 1423-0410, Vol. 109, no 4, 343-352 p.Article in journal (Refereed) PublishedText
Abstract [en]

Background and Objectives A photochemical treatment process (PCT) utilizing amotosalen and UVA light (INTERCEPT (TM) Blood System) has been developed for inactivation of viruses, bacteria, parasites and leucocytes that can contaminate blood components intended for transfusion. The objective of this study was to further characterize the safety profile of INTERCEPT-treated platelet components (PCT-PLT) administered across a broad patient population. Materials and Methods This open-label, observational haemovigilance programme of PCT-PLT transfusions was conducted in 21 centres in 11 countries. All transfusions were monitored for adverse events within 24 h post-transfusion and for serious adverse events (SAEs) up to 7 days post-transfusion. All adverse events were assessed for severity (Grade 0-4), and causal relationship to PCT-PLT transfusion. Results Over the course of 7 years in the study centres, 4067 patients received 19 175 PCT-PLT transfusions. Adverse events were infrequent, and most were of Grade 1 severity. On a per-transfusion basis, 123 (0.6%) were classified an acute transfusion reaction (ATR) defined as an adverse event related to the transfusion. Among these ATRs, the most common were chills (77, 0.4%) and urticaria (41, 0.2%). Fourteen SAEs were reported, of which 2 were attributed to platelet transfusion (<0.1%). No case of transfusion-related acute lung injury, transfusion-associated graft-versus-host disease, transfusion-transmitted infection or death was attributed to the transfusion of PCT-PLT. Conclusion This longitudinal haemovigilance safety programme to monitor PCT-PLT transfusions demonstrated a low rate of ATRs, and a safety profile consistent with that previously reported for conventional platelet components.

Place, publisher, year, edition, pages
2015. Vol. 109, no 4, 343-352 p.
Keyword [en]
amotosalen, haemovigilance, INTERCEPT, pathogen inactivation, platelets, safety
National Category
URN: urn:nbn:se:uu:diva-271041DOI: 10.1111/vox.12287ISI: 000365413400006PubMedID: 25981525OAI: diva2:891103
Available from: 2016-01-05 Created: 2016-01-05 Last updated: 2016-01-25Bibliographically approved

Open Access in DiVA

fulltext(137 kB)24 downloads
File information
File name FULLTEXT01.pdfFile size 137 kBChecksum SHA-512
Type fulltextMimetype application/pdf

Other links

Publisher's full textPubMed

Search in DiVA

By author/editor
Knutson, Folke
By organisation
Department of Immunology, Genetics and Pathology
In the same journal
Vox Sanguinis

Search outside of DiVA

GoogleGoogle Scholar
Total: 24 downloads
The number of downloads is the sum of all downloads of full texts. It may include eg previous versions that are now no longer available

Altmetric score

Total: 59 hits
ReferencesLink to record
Permanent link

Direct link