NCT03405402

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

February 13, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2020

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

2.5 years

First QC Date

January 12, 2018

Last Update Submit

January 27, 2021

Conditions

Sickle Cell Disease

Keywords

Sickle cell diseaseAllo-immunizationBlood transfusion

Outcome Measures

Primary Outcomes (9)

  • Irregular antibodies

    Presence/abscence of irregular antibodies

    1 hour before blood transfusion

  • Irregular antibodies

    Presence/abscence of irregular antibodies

    Between 2 to 4 weeks after blood transfusion

  • C-reactive protein (CRP)

    CRP dosage

    1 hour before blood transfusion

  • Cytokine

    Cytokine dosage

    1 hour before blood transfusion

  • Cytokine

    Cytokine dosage

    Between 2 to 4 weeks after blood transfusion

  • Heme oxygenase

    Heme oxygenase dosage

    1 hour before blood transfusion

  • Heme oxygenase

    Heme oxygenase dosage

    Between 2 to 4 weeks after blood transfusion

  • Lymphocyte typing

    Lymphocyte typing

    1 hour before blood transfusion

  • Lymphocyte typing

    Lymphocyte typing

    Between 2 to 4 weeks after blood transfusion

Secondary Outcomes (4)

  • Sex

    1 hour before blood transfusion

  • Chronic or acute blood transfusion

    1 hour before blood transfusion

  • Blood transfusion indication

    1 hour before blood transfusion

  • Blood donor ethnicity

    1 hour before blood transfusion

Study Arms (2)

Experimental group

EXPERIMENTAL

Allo-immunization detected (positive response for irregular antibodies 2 to 4 weeks after a blood transfusion)

Procedure: Blood sampling

Control group

OTHER

Allo-immunization not detected

Procedure: Blood sampling

Interventions

Blood samplingPROCEDURE

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

Control groupExperimental group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Brugmann

Brussels, 1020, Belgium

Location

HUDERF

Brussels, 1020, Belgium

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Marie Deleers, Ph Biol

    CHU Brugmann

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Blood Bank

Study Record Dates

First Submitted

January 12, 2018

First Posted

January 23, 2018

Study Start

February 13, 2018

Primary Completion

August 3, 2020

Study Completion

August 3, 2020

Last Updated

January 28, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

BE(2)