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Adverse Occurrence type:
The investigation involved the TRANSPOSE project initiated in September 2017 and included 25 associated partners from 15 European countries (https://www.transposeproject.eu). Participants/stakeholders reported complications (serious and non-serious) for blood, plasma, hematopoietic stem cells, gametes, embryos and tissues. Overall complication rates are presented in Table 1 of the manuscript and below. Specific types of complications are presented for whole blood and stem cells in manuscript Tables 3 and 5. Donors Report years Total donations Total complications Complication rate Whole blood 2014–2017 19 721 150 95 871 0.0049 (0.0049–0.0049) Plasma 2014–2017 1 979 972 12 577 0.0064 (0.0063–0.0065) Unspecified blood donation 2014–2017 15 848 803 37 012 0.0023 (0.0023–0.0023) Haematopoietic stem cells 2014–2017 10 744 135 0.0126 (0.0107–0.0149) Medically assisted reproduction 2015–2016 378 078 17 0.00004 (0.0–0.0) Tissues 2015–2016 42 405 0 0 The complication rates are presented as proportions (95% CI) of the total number of complications. Three countries provided the combined data forwhole blood and plasmapheresis. These are presented in the third row as ‘unspecified type of blood donation’
Time to detection:
No time to detection was provided but given the diverse set of donation types and complications it is likely that some were proximal to donation and some developed over time.
Alerting signals, symptoms, evidence of occurrence:
Highly diverse and dependent on donation and complication type.
Demonstration of imputability or root cause:
For the purpose of this report, all adverse reactions reported by participants were included regardless of level of imputability. However, it is clear from the types of complications reported that most are likely to be directly linked to donation.
Suggest new keywords:
donor complications, donor adverse events
1) Putting the spotlight on donation-related risks and donor safety - are we succeeding in protecting donors? Vox Sang. 2021 Mar;116(3):313-323 2) Validation of a standardized donor health questionnaire across substances of human origin. Vox Sang. 2021 Jul;116(6):645-655
Expert comments for publication:
The authors conclude that in Europe, donor complications are rare but are likely to be underreported. Complication reporting is non-standardized. The authors advocate a standardized donor vigilance system.