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Multicenter Study
. 2010 Jan;8(1):49-62.
doi: 10.2450/2009.0089-09.

Adverse reactions to blood donations: the READ project

Giovanni Garozzo  1 , Isabella Crocco, Barbara Giussani, Annalisa Martinucci, Stefano Monacelli, Vanda Randi
Affiliations
Multicenter Study

Adverse reactions to blood donations: the READ project

Giovanni Garozzo et al. Blood Transfus. 2010 Jan.

Abstract

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.

Keywords: Italian multicentre study; adverse events to donation; blood donation.

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Figures

Figure 1
Figure 1
Project READ
Figure 1
Figure 1
Project READ
Figure 2
Figure 2
Project READ
Figure 2
Figure 2
Project READ
Figure 3
Figure 3
Project READ
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Figure 3
Project READ
Figure 4
Figure 4
Total symptoms recorded: 978. The number of real, severe AE was 30, for an incidence of 0.03% among all the donations monitored
Figure 5
Figure 5
Therapy used to manage the 310 AE that were treated; the arrows indicate: (1): therapy for haematomas, (2): reduction of reinfusion, (3): transfer to the Accident and Emergency Department, (4): oxygen therapy
Figure 6
Figure 6
Flow chart of information
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