The DRAIHA study: Data Registry of AutoImmune Hemolytic Anemia, to improve diagnostic testing for the development of personalized treatment protocols in AIHA patients

The DRAIHA study: Data Registry of AutoImmune Hemolytic Anemia, to improve diagnostic testing for the development of personalized treatment protocols in AIHA patients - The DRAIHA study: Data Registry of AutoImmune Hemolytic Anemia

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54572

Enrollment

800

Registered

2017-07-11

Start date

2019-07-12

Completion date

Unknown

Last updated

2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

antibody mediated destruction of red blood cells

Interventions

None listed

Eligibility

Age

2 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with a positive DAT, a positive eluate and signs of hemolysis Patients with a positive DAT with complement only, negative eluate and sings of hemolysis Blood donors with a positive direct antiglobulin test and a positive eluate and/or clinically relevant cold auto-antibodies.

Exclusion criteria

Exclusion criteria: No informed consent Insufficient comprehension of the Dutch language

Design outcomes

Primary

Measure	Time frame
The main study parameter is to determine the causal contribution of the pathogenic characteristics of the autoantibody in relation to the clinical course of AIHA. We will study the autoantibody characteristics such as 1) isotype (IgG, sometimes IgM and rarely IgA class), 2) the ability to activate the complement system, 3) the optimal temperature for reactivity of the RBC autoantibodies, associated with so called warm AIHA or cold AIHA, 4) the nature of the antigen recognized and the interaction of IgG-Fc receptor, 5) the glycoprofile of the IgG-Fc fragment, and 6) other features of the autoantibodies which are related to the antibody-mediated effects, hence to the course of disease and response to therapy. Main study parameters obtained from the referring laboratories are hemoglobin levels and hemolysis parameters (LDH, haptoglobin, bilirubin). Main study parameters obtained from the questionnaire after 1-1,5 year are 1) number of red cell transfusions, 2) number and type of therapy, 3) response of hemoglobin level after each therapy.	—

Measure

Time frame

The main study parameter is to determine the causal contribution of the pathogenic characteristics of the autoantibody in relation to the clinical course of AIHA. We will study the autoantibody characteristics such as 1) isotype (IgG, sometimes IgM and rarely IgA class), 2) the ability to activate the complement system, 3) the optimal temperature for reactivity of the RBC autoantibodies, associated with so called *warm AIHA* or *cold AIHA*, 4) the nature of the antigen recognized and the interaction of IgG-Fc receptor, 5) the glycoprofile of the IgG-Fc fragment, and 6) other features of the autoantibodies which are related to the antibody-mediated effects, hence to the course of disease and response to therapy. Main study parameters obtained from the referring laboratories are hemoglobin levels and hemolysis parameters (LDH, haptoglobin, bilirubin). Main study parameters obtained from the questionnaire after 1-1,5 year are 1) number of red cell transfusions, 2) number and type of therapy, 3) response of hemoglobin level after each therapy.

—

Secondary

Measure	Time frame
Study parameters for the secondary objectives of safe and efficient transfusion in AIHA patients are: development of alloantibodies; development of hyperhemolysis after transfusion; aggravation of hemolysis, based on hemolysis parameters after transfusion; aggravation of autoantibody reactivity after transfusion.	—

Countries

Netherlands

Contacts

Public ContactF.V.M. Mulder

Sanquin Bloedvoorziening

f.mulder@sanquin.nl0031-20512 3479

Outcome results