CompletedNCT03405402Updated Jan 28, 2021

Transfusion in Sickle Cell Disease: Risk Factors for Alloimmunization

An interventional study of Blood sampling in Sickle Cell Disease, sponsored by Hanane EL KENZ. Completed at 2 sites in Belgium. Per ClinicalTrials.gov, last updated 2021-01-28.

Sponsored by Hanane EL KENZ · Not applicable, Interventional, and Screening

Phase: Not applicable
Study type: Interventional
Enrollment: 173
Allocation: Non-randomized
Sex: All

Study 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.

Conditions studied

Sickle Cell Disease

Browse trials for

Anemia, Sickle Cell 1,134

Keywords

Sickle cell disease
Allo-immunization
Blood transfusion

In context

Anemia, Sickle Cell

1,134 studies on the registry are indexed under Anemia, Sickle Cell; 238 are open to participants now.

This study's enrollment of 173 is above the median of 40 across 769 interventional studies indexed under Anemia, Sickle Cell.

Browse Anemia, Sickle Cell studies →

Lead sponsor

Hanane EL KENZ is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

None

Study design

Phase: Not applicable
Primary purpose: Screening
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 173 participants (actual)

Study arms

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

Interventions

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

What researchers measure

Primary outcomes

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

Secondary outcomes

Sex
Sex
Time frame: 1 hour before blood transfusion
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).
Time frame: 1 hour before blood transfusion
Blood transfusion indication
Medical reason explaining the necessity of a blood transfusion
Time frame: 1 hour before blood transfusion
Blood donor ethnicity
Blood donor ethnicity
Time frame: 1 hour before blood transfusion

Study locations

2 sites

CHU Brugmann
Brussels, 1020, Belgium
HUDERF
Brussel, 1020, Belgium

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2018 to primary completion in Aug 2020, 29 months.

Of 165 non-industry interventional studies with no phase under Anemia, Sickle Cell, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 54. This study's 29 months is close to that.

Counting every sponsor, half of 173 studies reached it within 28 months; a quarter within 15 and three quarters within 49.

How these figures are worked out, and which studies are left out of them.

Registered: Jan 12, 2018
First posted: Jan 23, 2018
StartActual: Feb 13, 2018
Primary completionActual: Aug 3, 2020
CompletionActual: Aug 3, 2020
Last update: Jan 28, 2021

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jan 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03405402
Lead sponsor: Hanane EL KENZ
Responsible party: Hanane EL KENZ (Head of Blood Bank, Brugmann University Hospital) — Sponsor-investigator
First posted: Jan 23, 2018
Start date: Feb 13, 2018
Primary completion: Aug 3, 2020
Completion: Aug 3, 2020
Last update: Jan 28, 2021

Study contacts

Marie Deleers, Ph Biol

principal investigator · CHU Brugmann

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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