Transfusion in Sickle Cell Disease: Risk Factors for Alloimmunization

• ClinicalTrials.gov Identifier: NCT03405402
• Recruitment Status: Completed
• First Posted: January 23, 2018
• Last Update Posted: January 28, 2021
• Sponsor: Hanane EL KENZ
• Information provided by (Responsible Party): Hanane EL KENZ, Brugmann University Hospital

Tracking Information

• First Submitted Date: January 12, 2018
• First Posted Date: January 23, 2018
• Last Update Posted Date: January 28, 2021
• Actual Study Start Date: February 13, 2018
• Actual Primary Completion Date: August 3, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 19, 2018)

• Irregular antibodies [ Time Frame: 1 hour before blood transfusion ]
  Presence/abscence of irregular antibodies
• Irregular antibodies [ Time Frame: Between 2 to 4 weeks after blood transfusion ]
  Presence/abscence of irregular antibodies
• C-reactive protein (CRP) [ Time Frame: 1 hour before blood transfusion ]
  CRP dosage
• Cytokine [ Time Frame: 1 hour before blood transfusion ]
  Cytokine dosage
• Cytokine [ Time Frame: Between 2 to 4 weeks after blood transfusion ]
  Cytokine dosage
• Heme oxygenase [ Time Frame: 1 hour before blood transfusion ]
  Heme oxygenase dosage
• Heme oxygenase [ Time Frame: Between 2 to 4 weeks after blood transfusion ]
  Heme oxygenase dosage
• Lymphocyte typing [ Time Frame: 1 hour before blood transfusion ]
  Lymphocyte typing
• Lymphocyte typing [ Time Frame: Between 2 to 4 weeks after blood transfusion ]
  Lymphocyte typing

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 19, 2018)

• Sex [ Time Frame: 1 hour before blood transfusion ]
  Sex
• Chronic or acute blood transfusion [ Time Frame: 1 hour before 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 [ Time Frame: 1 hour before blood transfusion ]
  Medical reason explaining the necessity of a blood transfusion
• Blood donor ethnicity [ Time Frame: 1 hour before blood transfusion ]
  Blood donor ethnicity

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Transfusion in Sickle Cell Disease: Risk Factors for Alloimmunization
• Official Title: Transfusion in Sickle Cell Disease: Risk Factors for Alloimmunization

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Screening
• Condition: Sickle Cell Disease

Intervention

Procedure: Blood sampling

Extra blood sampling at the time of a blood transfusion in order to perform the laboratory analysis

Study Arms

• Experimental: Experimental group
  Allo-immunization detected (positive response for irregular antibodies 2 to 4 weeks after a blood transfusion)
  Intervention: Procedure: Blood sampling
• Control group
  Allo-immunization not detected
  Intervention: Procedure: Blood sampling

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 27, 2021): 173
• Original Estimated Enrollment (submitted: January 19, 2018): 100
• Actual Study Completion Date: August 3, 2020
• Actual Primary Completion Date: August 3, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

Sickle cell disease patients treated within the CHU Brugmann or Queen Fabiola Children's Hospital

Exclusion Criteria:

None

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium

Administrative Information

• NCT Number: NCT03405402
• Other Study ID Numbers: CHUB-PRO-TRANSFU-DREPANO 1
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Hanane EL KENZ, Brugmann University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Hanane EL KENZ
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Marie Deleers, Ph Biol; CHU Brugmann

• PRS Account: Brugmann University Hospital
• Verification Date: January 2021