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Sickle Cell Disease: Targeting Alloantibody Formation Reduction; Risk Factors, and Genetics

Sickle Cell Disease: Targeting Alloantibody Formation Reduction; Risk Factors, and Genetics

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03288012
Acronym
STARRING
Enrollment
150
Registered
2017-09-19
Start date
2017-09-20
Completion date
2021-12-31
Last updated
2019-07-19

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

Conditions

Alloimmunization, Sickle Cell Disease

Brief summary

The focus of the study is the pathophysiological mechanism of allo-antibody formation after red blood cell transfusion in sickle cell disease patients.

Detailed description

The main objectives of this study are to study the role of the innate and adaptive immune response in allo-antibody formation and furthermore to identify the genetic and time dependent clinical risk factors on alloimmunization in SCD patients. Subjects without allo-antibodies, receiving a red blood cell transfusion, will be included in this study. At 5 time points blood will be drawn from these subjects. (T0: Before transfusion, T1: 1 day after transfusion, T2: 1 week after transfusion, T3: 4 weeks after transfusion, T4: 6 months after transfusion). At each time point specific markers of the immune system will be measured.

Interventions

None listed

Sponsors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
CollaboratorOTHER
Radboud University Medical Center
CollaboratorOTHER
HagaZiekenhuis
CollaboratorOTHER
Erasmus Medical Center
CollaboratorOTHER
Sanquin Research & Blood Bank Divisions
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Sickle cell disease * Receiving a red blood cell transfusion

Exclusion criteria

* Previous positive screen for allo-antibodies * \>25 red blood cell units in the past

Design outcomes

Primary

MeasureTime frameDescription
The innate and adaptive immune response of patients with sickle cell disease that form allo-antibodies following erythrocyte transfusion, compared to patients that do not form alloantibodies following erythrocyte transfusion6 monthsMultiple activating and regulatory markers of the innate and adaptive immune system will be measured at the indicated time points and compared between cases and controls

Countries

Netherlands

Contacts

Primary ContactKarin Fijnvandraat, MD PhD
k.fijnvandraat@sanquin.nl+31205123122

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026