Abstract Background and Objectives
Haemolysis can occur following intravenous immunoglobulin (IVIG) infusion. Haemovigilance data were analysed using a novel approach for including two control groups with no haemolysis to IVIG. Objectives included a summary of all reactions to IVIG, rate estimates and analysis of haemolytic reactions including risk factors.
Materials and Methods
Canadian haemovigilance data from Ontario (2013–2021), IVIG distribution and transfusion data from the blood supplier, and data from a large local transfusion registry were used. An ‘other‐reactions’ control group included patients with IVIG reactions that were not haemolytic, and registry patients with no‐reaction were the ‘no‐reaction controls’. Descriptive analysis and two logistic regression models for the different control groups were performed.
One thousand one hundred and seventy reactions were included. Most common were febrile non haemolytic (26.1%), minor allergic (24.5%) and IVIG headache (15.3%) followed by haemolytic 10.9% (128/1170). Haemolytic reaction rates decreased over time: rates since 2020 estimated between 1.5 and 2.9/1000 kg IVIG used. The regression model for other‐reaction controls identified two risk factors for haemolysis: non‐O blood group recipients compared with group O recipients (
pvalue = 0.0106) and IVIG dose per 10 g increase (OR 1.359; 95% CI 1.225–1.506). The model using no‐reaction controls gave similar results and also showed no pre‐medication was associated with a higher risk of haemolysis (OR 29.084; 95% CI 1.989–425.312). Conclusion
The frequency of haemolytic reactions has decreased over time. We confirmed non‐O blood group recipients and IVIG dose as risk factors for haemolysis and raise the hypothesis that no pre‐medication may increase the risk of haemolysis.