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

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ClinicalTrials.gov Identifier: NCT03288012
Recruitment Status : Unknown
Verified August 2018 by Sanquin Research & Blood Bank Divisions.
Recruitment status was:  Recruiting
First Posted : September 19, 2017
Last Update Posted : July 19, 2019
Sponsor:
Collaborators:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Radboud University Medical Center
HagaZiekenhuis
Erasmus Medical Center
Information provided by (Responsible Party):
Sanquin Research & Blood Bank Divisions

Study Description
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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.

Condition or disease
Alloimmunization Sickle Cell Disease

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sickle Cell Disease: Targeting Alloantibody Formation Reduction; Risk Factors, and Genetics
Actual Study Start Date : September 20, 2017
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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 transfusion [ Time Frame: 6 months ]
    Multiple 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


Biospecimen Retention:   Samples With DNA
Blood samples for DNA analysis and analysis of immune system components involved in alloimmune reactions following erythrocyte transfusion

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Sickle cell disease population receiving care in the participating hospitals
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03288012


Contacts
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Contact: Karin Fijnvandraat, MD PhD +31205123122 k.fijnvandraat@sanquin.nl

Locations
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Netherlands
Academic Medical Center Amsterdam Recruiting
Amsterdam-Zuidoost, Netherlands
Contact: Karin Fijnvandraat, PhD    +31 02 5123122    c.j.fijnvandraat@amc.nl   
HagaZiekenhuis Not yet recruiting
Den Haag, Netherlands
Contact: Jean Louis Kerkhoffs, PhD         
Principal Investigator: Jean-Louis Kerkhoffs, PhD         
Radboudumc Recruiting
Nijmegen, Netherlands
Contact: S Schols, MD    0031243618800      
Erasmus MC Recruiting
Rotterdam, Netherlands
Contact: Marjon Cnossen, PhD         
Principal Investigator: Marjon Cnossen, PhD         
Sponsors and Collaborators
Sanquin Research & Blood Bank Divisions
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Radboud University Medical Center
HagaZiekenhuis
Erasmus Medical Center
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Sanquin Research & Blood Bank Divisions
ClinicalTrials.gov Identifier: NCT03288012    
Other Study ID Numbers: NL60834.018.17
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn