Autoimmune Hemolytic Anemia Clinical Trial
Official title:
The DRAIHA Study: Data Registry of AutoImmune Hemolytic Anemia, to Improve Diagnostic Testing for the Development of Personalized Treatment Protocols in AIHA Patients
In autoimmune hemolytic anemia (AIHA) auto-antibodies directed against red blood cells (RBCs)
lead to increased RBC clearance (hemolysis). This can result in a potentially
life-threatening anemia. AIHA is a rare disease with an incidence of 1-3 per 100,000
individuals. An unsolved difficulty in diagnosis of AIHA is the laboratory test accuracy. The
current 'golden standard' for AIHA is the direct antiglobulin test (DAT). The DAT detects
autoantibody- and/or complement-opsonized RBCs. The DAT has insufficient test characteristics
since it remains falsely negative in approximate 5-10% of patients with AIHA, whereas a
falsely positive DAT can be found in 8% of hospitalized individuals. Also apparently healthy
blood donors can have a positive DAT. The consequences of DAT positivity are not well known
and may point to early, asymptomatic disease, or to another disease associated with formation
of RBC autoantibodies, such as a malignancy or (systemic) autoimmune disease. Currently,
there are no guidelines to follow-up DAT positive donors.
A second unsolved difficulty is the choice of treatment in AIHA. Hemolysis can be stopped or
at least attenuated with corticosteroids, aiming to inhibit autoantibody production and/or
RBC destruction. Many patients do not respond adequately to corticosteroid treatment or
develop severe side effects.
Currently, it is advised to avoid RBC transfusions since these may lead to aggravation of
hemolysis and RBC alloantibody formation. But in case symptomatic anemia occurs, RBC
transfusions need to be given. An evidence-based transfusion strategy for AIHA patients is
needed to warrant safe transfusion in this complex patient group.
To design optimal diagnostic testing and (supportive) treatment algorithms, the investigators
will study a group well-characterized patients with AIHA and blood donors without AIHA, via a
prospective centralized clinical data collection and evaluation of new laboratory tests. With
this data the knowledge of the AIHA pathophysiology and to evaluate diagnostic testing in
correlation with clinical features and treatment outcome can be improved.
n/a
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