Measuring survival of transfused red blood cells in patients with Sickle cell disease and ß-Thalassemia: A Biotin Label approach

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON25329

Enrollment

Registered

2019-05-16

Start date

2019-05-20

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Sickle cell disease & ß-thalassemia

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: • Patient with either sickle cell disease (HbSS/HbSß0/HbSC/HbSß+) or ß-thalassemia (major or transfusion dependent thalassemia intermedia) • Currently on chronic transfusion program. • >18 years of age

Exclusion criteria

Exclusion criteria: No venous access for blood drawings

Design outcomes

Primary

Measure	Time frame
The primary outcome is the survival of transfused RBCs in patients with sickle cell disease and ß-thalassemia.	—

Secondary

Measure	Time frame
Inter patient study parameters will focus on the effects of the transfusion. The main parameters will be: • Inflammatory/immunomodulatory response on transfused RBCs. • Influence of previous responder status on RBC survival. • Antibody formation to the biotin label. Intra patient study parameters will focus on the effect of matching of the RBC units. Both units will be matched differentially. The main parameters will be: • The recovery, short term and long term survival of both RBC units. • The (immediate and late) host immune response to both RBC units by measuring effect on expression of markers of clearance and inflammation as well as transcriptome analysis.	—

Measure

Time frame

Inter patient study parameters will focus on the effects of the transfusion. The main parameters will be: • Inflammatory/immunomodulatory response on transfused RBCs. • Influence of previous responder status on RBC survival. • Antibody formation to the biotin label. Intra patient study parameters will focus on the effect of matching of the RBC units. Both units will be matched differentially. The main parameters will be: • The recovery, short term and long term survival of both RBC units. • The (immediate and late) host immune response to both RBC units by measuring effect on expression of markers of clearance and inflammation as well as transcriptome analysis.

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Contacts

Public ContactKarin Fijnvandraat

Amsterdam UMC

j.j.gerritsma@amsterdamumc.nl020-5668668

Outcome results