Intravenous immune globulin–related hemolysis: comparing two different methods for case assessment

Taylor, Erik A.; Vu, Duc; Legare, Carole; Keene, Daniel

doi:10.1111/trf.13096

Cited by 11 publications

(16 citation statements)

References 6 publications

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“…This would have allowed better characterization of clinical and laboratory factors associated with hemolysis after IVIG infusion, in that those patients who had follow‐up CBCs were likely not fully representative of the larger cohort. Also due to our retrospective design, a full workup for hemolysis as described by the Canadian IVIG Pharmacovigilance Group was not always feasible . However, a 2016 study characterized the natural history of anemia in a cohort of 100 KD patients, finding a mean decrease in Hb level of 0.7 g/dL during the acute phase of disease .…”

Section: Discussionmentioning

confidence: 99%

“…Also due to our retrospective design, a full workup for hemolysis as described by the Canadian IVIG Pharmacovigilance Group was not always feasible. 27 However, a 2016 study characterized the natural history of anemia in a cohort of 100 KD patients, finding a mean decrease in Hb level of 0.7 g/dL during the acute phase of disease. 15 In contrast, our patients with hemolysis suffered a mean decrement of 5.0 g/dL.…”

Section: Discussionmentioning

confidence: 99%

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High‐dose intravenous immunoglobulin is strongly associated with hemolytic anemia in patients with Kawasaki disease

et al. 2018

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BACKGROUND Hemolysis is a reported side effect of intravenous immunoglobulin (IVIG) therapy in adults, but pediatric data are scarce. We determined the frequency of IVIG‐associated hemolysis in patients with Kawasaki disease (KD) and characterized risk factors for hemolysis. We hypothesized that hemolysis is more common in children with KD than adults with other disorders, and hemolysis risk is related to IVIG dose and degree of inflammation. STUDY DESIGN AND METHODS This was an 8‐year, single‐center, retrospective cohort study. A total of 419 KD patients were identified; 123 had pre‐ and post‐treatment complete blood counts allowing for assessment of anemia. Hemolytic anemia was defined as decrease in hemoglobin after IVIG greater than 1 g/dL with immunohematologic or biochemical studies supporting hemolysis. RESULTS 123 patients were stratified as having hemolysis (n = 18, 15%) or nonhemolysis (n = 105, 85%). Patients with hemolysis were more likely to have complete versus incomplete KD (65% vs. 39%, p = 0.04) and refractory versus nonrefractory course (78% vs. 16%, p < 0.001). Patients receiving 4 g/kg versus 2 g/kg IVIG were more likely to hemolyze (89% vs. 34%, p < 0.001). Patients with hemolysis had mostly non‐O blood group (94%), positive direct antiglobulin tests (89%), and positive eluates (72%). Two‐thirds of patients with hemolysis required RBC transfusion. CONCLUSIONS Hemolysis occurred in 15% of KD patients evaluated for anemia and is strongly associated with high‐dose (4 g/kg) IVIG. KD patients receiving high‐dose IVIG should have close hematologic monitoring to identify hemolysis.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

High‐dose intravenous immunoglobulin is strongly associated with hemolytic anemia in patients with Kawasaki disease

et al. 2018

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“…Donor-recipient sex mismatch [270–273] and/or age [271, 273] of the blood donor has been shown to be associated with an increased risk of mortality. For example, receiving a red cell product from young (<45 years) female blood donor has been associated with up to an 8% increase in the risk of death for each unit transfused compared to receiving an RCC transfusion from a male door [271].…”

Section: Overview: Quality Assessment Of Stored Red Cell Concentratesmentioning

confidence: 99%

Quality Assessment of Established and Emerging Blood Components for Transfusion

Acker

Marks

Sheffield

2016

Journal of Blood Transfusion

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Blood is donated either as whole blood, with subsequent component processing, or through the use of apheresis devices that extract one or more components and return the rest of the donation to the donor. Blood component therapy supplanted whole blood transfusion in industrialized countries in the middle of the twentieth century and remains the standard of care for the majority of patients receiving a transfusion. Traditionally, blood has been processed into three main blood products: red blood cell concentrates; platelet concentrates; and transfusable plasma. Ensuring that these products are of high quality and that they deliver their intended benefits to patients throughout their shelf-life is a complex task. Further complexity has been added with the development of products stored under nonstandard conditions or subjected to additional manufacturing steps (e.g., cryopreserved platelets, irradiated red cells, and lyophilized plasma). Here we review established and emerging methodologies for assessing blood product quality and address controversies and uncertainties in this thriving and active field of investigation.

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“…7,8,15,16,20 The association between hemolysis and IVIG has not been confirmed in all published cases. 17,[21][22][23][24][25][26][27] The true incidence of hemolysis is difficult to estimate because data on the number of patients receiving any particular dose of any individual product are not available, and reporting of AEs is voluntary. 22,26,27 Additionally, most patients with minor laboratory findings may remain undiagnosed, as they rarely develop clinically significant hemolysis.…”

Section: Results: Twenty-one Patients Received One Infusionmentioning

confidence: 99%

“…The association between hemolysis and IVIG has not been confirmed in all published cases . The true incidence of hemolysis is difficult to estimate because data on the number of patients receiving any particular dose of any individual product are not available, and reporting of AEs is voluntary .…”

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confidence: 99%

Hemolysis related to intravenous immunoglobulins is dependent on the presence of anti‐blood group A and B antibodies and individual susceptibility

et al. 2017

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BACKGROUND Patients treated with intravenous immunoglobulins (IVIG) rarely experience symptomatic hemolysis. Although anti‐A and anti‐B isoagglutinins from the product are involved in most cases, the actual mechanisms triggering hemolysis are unclear. STUDY DESIGN AND METHODS A prospective, open‐label, multicenter, single‐arm clinical trial in 57 patients with immune thrombocytopenia treated with IVIG (Privigen, CSL Behring) was conducted. RESULTS Twenty‐one patients received one infusion (1 g/kg) and 36 received two infusions (2 × 1 g/kg) of IVIG. After a study duration of more than 2 years, no cases of clinically significant hemolysis as defined in the protocol were identified. Data of patients with mild hematologic and biochemical changes were analyzed in more detail. Twelve cases (10/23 patients with blood group A1 and 2/11 patients with blood group B, all having received 2 g/kg IVIG) were adjudicated as mild hemolysis (median hemoglobin [Hb] decrease, −3.0 g/dL); Hb decreases were transient, with partial or full recovery achieved by last visit. Eighteen patients (31.6%), all with non‐O blood group, of whom 16 (88.9%) received 2 g/kg IVIG, fulfilled post hoc criteria for hemolytic laboratory reactions. Red blood cell (RBC) eluates of all direct antiglobulin test–positive samples were negative for non‐ABO blood group antibodies. Blood groups A and B antigen density on RBCs appeared to be a risk factor for hemolytic laboratory reactions. Platelet response to treatment was observed in 42 patients (74%); eight of 12 patients with complete response had blood group A1. CONCLUSION Isoagglutinins are involved in clinically nonsignificant hemolysis after treatment with IVIG, but individual susceptibility varies greatly.

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Intravenous immune globulin–related hemolysis: comparing two different methods for case assessment

Abstract: The number of case reports per year received for the adverse event "hemolytic disorder" after exposure to IVIG fluctuated. The number of confirmed case reports varied depending on the case definition being used.

Cited by 11 publications

References 6 publications

High‐dose intravenous immunoglobulin is strongly associated with hemolytic anemia in patients with Kawasaki disease

High‐dose intravenous immunoglobulin is strongly associated with hemolytic anemia in patients with Kawasaki disease

Quality Assessment of Established and Emerging Blood Components for Transfusion

Hemolysis related to intravenous immunoglobulins is dependent on the presence of anti‐blood group A and B antibodies and individual susceptibility

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