Transfusion in Sickle Cell Disease: Risk Factors for Alloimmunization
Primary Purpose
Sickle Cell Disease
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Blood sampling
Sponsored by
About this trial
This is an interventional screening trial for Sickle Cell Disease focused on measuring Sickle cell disease, Allo-immunization, Blood transfusion
Eligibility Criteria
Inclusion Criteria:
Sickle cell disease patients treated within the CHU Brugmann or Queen Fabiola Children's Hospital
Exclusion Criteria:
None
Sites / Locations
- CHU Brugmann
- HUDERF
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Experimental group
Control group
Arm Description
Allo-immunization detected (positive response for irregular antibodies 2 to 4 weeks after a blood transfusion)
Allo-immunization not detected
Outcomes
Primary Outcome Measures
Irregular antibodies
Presence/abscence of irregular antibodies
Irregular antibodies
Presence/abscence of irregular antibodies
C-reactive protein (CRP)
CRP dosage
Cytokine
Cytokine dosage
Cytokine
Cytokine dosage
Heme oxygenase
Heme oxygenase dosage
Heme oxygenase
Heme oxygenase dosage
Lymphocyte typing
Lymphocyte typing
Lymphocyte typing
Lymphocyte typing
Secondary Outcome Measures
Sex
Sex
Chronic or acute blood transfusion
Blood transfusions planned at regular intervals of time (chronic transfusions) or performed in reaction to a medical issue (acute transfusion).
Blood transfusion indication
Medical reason explaining the necessity of a blood transfusion
Blood donor ethnicity
Blood donor ethnicity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03405402
Brief Title
Transfusion in Sickle Cell Disease: Risk Factors for Alloimmunization
Official Title
Transfusion in Sickle Cell Disease: Risk Factors for Alloimmunization
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
February 13, 2018 (Actual)
Primary Completion Date
August 3, 2020 (Actual)
Study Completion Date
August 3, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hanane EL KENZ
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Sickle cell patients have a high prevalence of alloimmunization. This high rate of alloimmunization can be partially explained by the existence of an antigenic difference between the predominantly Caucasian donor population and the sickle cell patients of African origin. Genetic and environmental risk factors have also been described.
The main risk factors that have been shown in retrospective or cross-sectional studies are some HLA alleles, the age of the patient, the number of leukocyte-depleted erythrocyte concentrates (CED) transfused, the number of transfusion episodes, the age of the CEDs, the existence of an inflammatory event at the time of transfusion and the presence of anti-erythrocyte autoantibodies.There is also evidence of an impaired TH response but the underlying immunological mechanism is not fully understood.
The aim of this study is to study the prevalence and the risk factors for anti-erythrocyte alloimmunization and to try to understand the immunological mechanisms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease
Keywords
Sickle cell disease, Allo-immunization, Blood transfusion
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
173 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Allo-immunization detected (positive response for irregular antibodies 2 to 4 weeks after a blood transfusion)
Arm Title
Control group
Arm Type
Other
Arm Description
Allo-immunization not detected
Intervention Type
Procedure
Intervention Name(s)
Blood sampling
Intervention Description
Extra blood sampling at the time of a blood transfusion in order to perform the laboratory analysis
Primary Outcome Measure Information:
Title
Irregular antibodies
Description
Presence/abscence of irregular antibodies
Time Frame
1 hour before blood transfusion
Title
Irregular antibodies
Description
Presence/abscence of irregular antibodies
Time Frame
Between 2 to 4 weeks after blood transfusion
Title
C-reactive protein (CRP)
Description
CRP dosage
Time Frame
1 hour before blood transfusion
Title
Cytokine
Description
Cytokine dosage
Time Frame
1 hour before blood transfusion
Title
Cytokine
Description
Cytokine dosage
Time Frame
Between 2 to 4 weeks after blood transfusion
Title
Heme oxygenase
Description
Heme oxygenase dosage
Time Frame
1 hour before blood transfusion
Title
Heme oxygenase
Description
Heme oxygenase dosage
Time Frame
Between 2 to 4 weeks after blood transfusion
Title
Lymphocyte typing
Description
Lymphocyte typing
Time Frame
1 hour before blood transfusion
Title
Lymphocyte typing
Description
Lymphocyte typing
Time Frame
Between 2 to 4 weeks after blood transfusion
Secondary Outcome Measure Information:
Title
Sex
Description
Sex
Time Frame
1 hour before blood transfusion
Title
Chronic or acute blood transfusion
Description
Blood transfusions planned at regular intervals of time (chronic transfusions) or performed in reaction to a medical issue (acute transfusion).
Time Frame
1 hour before blood transfusion
Title
Blood transfusion indication
Description
Medical reason explaining the necessity of a blood transfusion
Time Frame
1 hour before blood transfusion
Title
Blood donor ethnicity
Description
Blood donor ethnicity
Time Frame
1 hour before blood transfusion
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Sickle cell disease patients treated within the CHU Brugmann or Queen Fabiola Children's Hospital
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Deleers, Ph Biol
Organizational Affiliation
CHU Brugmann
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Brugmann
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Facility Name
HUDERF
City
Brussel
ZIP/Postal Code
1020
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Transfusion in Sickle Cell Disease: Risk Factors for Alloimmunization
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