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No

Background

The new Transfusion Law opens the door for eligibility testing of whole blood donors (WBD) by a remote physician via telemedicine. Thus the incidence of severe adverse events (SAE) requiring immediate medical intervention is a matter of debate. In order to estimate to what extent a physician may be dispensible, we analyzed the incidences of AE and SAE according to the IHN classification among a total of 983.532 repeat (RD) and 78.192 first-time-donors (FTD) in 2023.

Methods

We analyzed all whole blood donations at the German Red Cross Blood Donation Services Baden-Württemberg - Hessia (BWH) and North-East (NE) in 2023 with regard to the occurance and severity of AE. The incidence of all AE and SAE were clustered according to the IHN classification for SAE requiring immediate medical treatment: 1. systemic reactions: vasovagal reaction (VVR) requiring medication, reaction with loss of consciousness (LOC) <60s, LOC >60s, hypertension, sickness, arrythmia, seizure, injury following VVR, injury related to WBD, cerebrovascular accident, allergic reaction, others; and 2. local reactions: infiltration, nerve injury, arterial puncture, local allergic reaction, cellulitis, thrombophlebitis and arteriovenous fistula.

Results

We observed a total of 34.892 AE in RD (3.5% of all donations) and 7.583 AE in FTD (9.7%). Out of these, 2.477 (RD) and 1.435 (FTD) were classified as SAE as they required medical treatment by a physician. Thus the ratio of SAE was 1 in 397 donations and 1 in 54 for RD and FTD, respectively. Notably this ratio correlated inversely with age and was highest in FTD donors < 24 yrs. (1 in 37) and RD < 24 years (1 in 105). In contrast, donors at age 60-64yrs had 1 in 938 AE (RD) and 1 in 174 (FTD) and donors at age 65-69yrs. had 1 in 862 (RD) and 1 in 180 (FTD) SAE. Furthermore systemic SAE requring medical treatment were much more frequent versus local both in RD (1 in 434 vs. 1 in 4.684) and FTD (1 in 58 vs. 1 in 850).

Conclusion

We observe a frequency of 1 in every 397 whole blood donation by RD and 1 in 54 FTD. With the introduction of telemedicine and the absence of a physician on-site, adapted strategies for an immediate medical intervention have to be introduced in case of SAE. Further investigations will be necessary in order not put WBD at risk carelessly. The incidence of SAE is not only correlated to the donor status but is also inversely correlated to age identifying young RD and FTD as the most vulnerable cohort.