Adverse reactions to blood donations: the READ project.

BACKGROUND: In 2006 in Italy 2,404,267 donations of blood components were made by 1,539,454 donors; approximately 55% of the donations were collected directly by Transfusion Structures (TS), while about 45% were collected in Donation Centres managed by Associations and Federations of Donors. The aim of the READ (Rilevamento Eventi Avversi alla Donazione) project is to create a network of TS to test a standardised system for monitoring adverse events (AE) related to blood donations. MATERIALS AND METHODS: Shared, standardised data collection forms, compatible with the forms produced by the ISBT-EHN, were prepared. Two types of form were used: (i) a form to collect data on single events (READ 1), to be used at the individual collection sites; (ii) a form for processing the data collected by each TS (READ 2). RESULTS: Between February and August 2008 six TS collected data related to the donation of 89,332 units of blood. Overall, 523 AE were recorded. The AE occurred in 0.59% of the donations. The mean duration of the symptoms was 17 minutes. Fifteen percent of the symptoms were related to the venipuncture (mainly haematomas) and 77% to vasovagal AE. The AE were defined severe (grade C) in 47 cases. The donations in which AE were recorded were completed in 81% of the cases; 59% of the AE did not require treatment. Three donors were monitored briefly (for less than 4 hours) in hospital. CONCLUSIONS: The use of standardised forms enabled the collection of data that could be analysed. Some problems related to the performance of the haemovigilance programme did, however, emerge: (i) organisational problems, (ii) limited sensitivity, (iii) inadequate training, and (iv) poorly defined responsibilities. These problems must be resolved at various levels: local, regional and national.

Adverse reactions in blood and apheresis donors: experience from two Italian transfusion centres.

BACKGROUND: Blood and apheresis donations are widely considered to be safe with a low incidence of adverse reactions and injuries; however, data reported in the medical literature on the prevalence of adverse events in donors and studies on the predictive risk factors for donor reactions are limited and contradictory. METHODS: From January 2002 to December 2006 we recorded every adverse reaction verified during 240,596 consecutive blood and apheresis donations (183,855 homologous whole blood donations, 6,669 autologous whole blood donations, 38,647 plasmapheresis, 2,641 plateletpheresis and 8,784 multicomponent donations) at the Italian Transfusion Centres of Verona and Ragusa,. RESULTS: Using a special, pre-arranged form within the quality system, a total of 686 adverse reactions (related to 0.28% of all donations) were recorded. Vasovagal reactions, mostly of mild intensity, were the most commonly observed adverse reactions, with a frequency of 0.20% (487/ 240,596). The frequency of the vasovagal reactions varied according to the different types of donation, being 0.19% (346/183,855) for homologous whole blood donations, 0.24% (16/6,669) for autologous whole blood donations, 0.16% (63/38,647) for plasmapheresis, 0.68% (18/2,641) for plateletpheresis and 0.49 (43/8,784) for multicomponent donations. Citrate toxicity was reported in 0.38% (189/50,072) of apheresis donations. Severe adverse reactions were very rare, as they occurred in 0.004% of the donations (10/240,596). CONCLUSIONS: In conclusion, the results of our 5-year survey document that apheresis and blood donation are safe procedures for the donor with a low incidence of adverse reactions; the adverse reactions that did occur were mostly mild and resolved rapidly.