Adverse Events in Autologous Blood Donation and Plasmapheresis – a 6-Year Analysis in 28,244 Patients with 50,542 Donations

Abstract

Background: 6-year analysis of adverse events (AE) in a preoperative autologous deposit (PAD) program. Patients and Methods: This analysis was performed in 28,244 patients who underwent major bone and joint surgery from 1989 to 1994 and who took part in our PAD program. Patients were included into the PAD program if eligible for elective surgery with supposed blood loss requiring blood transfusion. Patient’s physical status was rated according to the ASA score. Blood or plasma volume donated was replaced routinely, mostly with polygeline. Monitoring during donation included ECG (lead II) and noninvasive blood pressure recording. Oxygen (2 l/min) was applied via nasal sponges. AE were rated as mild (grade I), moderate (grade II), severe (grade III), and fatal (grade IV). All AE happening in the blood bank were taken into account; additionally, all grade III and grade IV AE occurring within 24 h after PAD were considered, independent of a relationship between PAD and AE. AE were analyzed in relation to age and ASA status of the patients. Data were evaluated using descriptive statistics, chi-square test, and Spearman rank correlation; statistical significance was considered for p < 0.05. Results: 28,244 patients underwent 50,542 PAD sessions and donated a total of 132,093 autologous units. A total of 588 AE happened; i.e. in 2.08% of all participating patients and in 1.17% of all donations (not units obtained!). With increasing ASA score, i.e. with worsening of the patient’s physical status, the frequencies of mild and moderate AE decreased. 65.9% (n = 388) of all AE were considered as mild, 33.2% (n = 195) were rated as moderate, 0.51% (n = 3) were graded as severe, and 0.34% (n = 2) were fatal. No overall relation between patients’ age and frequency of AE could be demonstrated. However, patients over 70 years (21.1%) accounted for 30.7% of AE (p < 0.05). The rate of AE associated with autologous plasmapheresis was 3.4-times higher than that associated with autologous blood donation. With one exception, all severe and fatal AE were found in patients over 70 years with ASA score III and a history of cardio- or cerebrovascular diseases. All these patients had undergone autologous plasmapheresis. Conclusion: The overall frequency of AE in our PAD program was not higher than that reported for homologous programs. However, severe and fatal AE exclusively happened in patients who underwent autologous plasmapheresis. Therefore, in elderly patients and in those with concomitant cardio- or cerebrovascular diseases the indication for participation in a PAD/autologous plasmapheresis program has to be made very cautiously and by weighing pros and cons.