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CompletedNCT03405688Updated Jan 28, 2021

Transfusion in Sickle Cell Disease: Screening of Sickle Cell Disease Trait in Blood Donors

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

Primary conditionSickle Cell TraitRegistry: Anemia, Sickle CellReclassifiedWhy we changed it
Registry
Anemia, Sickle Cell — the first condition term the registry derived for this study.
ClinicalTrials.gg
Sickle Cell Trait
Why
  1. The study's listed conditions name Sickle Cell Trait, a narrower term within Anemia, Sickle Cell.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

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

Phase
Not applicable
Study type
Interventional
Enrollment
173
Allocation
Non-randomized
Sex
All
01

Study summary

Bearers of the sickle cell allele (S) are currently eligible for blood donations in Belgium. As blood donors are not tested for this allele, their heterozygous status is unknown. However, guidelines recommend to transfuse sickle cell patients with blood that is negative for the 'S' hemoglobin. To the investigator's knowledge, no study has been conducted to evaluate the impact of transfusion with blood originating from heterozygous donors on the transfusion performance and the improvement of clinical status of the sickle cell disease patients.

02

Conditions studied

  • Sickle Cell Disease
  • Sickle Cell Trait

Browse trials for

Keywords

  • Sickle cell
  • Heterozygous
  • Blood donor
03

In context

Sickle Cell Trait Reclassified

43 studies on the registry are indexed under Sickle Cell Trait; 11 are open to participants now.

This study's enrollment of 173 is above the median of 63 across 22 interventional studies indexed under Sickle Cell Trait.

Browse Sickle Cell Trait studies →

Lead sponsor

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

Compared within Sickle Cell Trait, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Anemia, Sickle Cell. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

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

All patients with sickle cell disease within the CHU Brugmann and the Queen Fabiola Children's Hospital (HUDERF)

Exclusion criteria

Exclusion Criteria:

None

05

Study design

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

Study arms

  • Experimental
    Acute transfusion

    Blood donor heterozygous for the sickle cell disease allele (HbAS genotype)

    Procedure: Blood sampling

  • Other
    Control - Acute transfusion

    Blood donor not bearer of the sickle cell disease allele (HbAA genotype)

    Procedure: Blood sampling

  • Experimental
    Chronic transfusion

    Blood donor heterozygous for the sickle cell disease allele (HbAS genotype)

    Procedure: Blood sampling

  • Other
    Control - Chronic transfusion

    Blood donor not bearer of the sickle cell disease allele (HbAA genotype)

    Procedure: Blood sampling

  • Experimental
    Transfusion prior to surgery

    Blood donor heterozygous for the sickle cell disease allele (HbAS genotype)

    Procedure: Blood sampling

  • Other
    Control - Transfusion prior to surgery

    Blood donor not bearer of the sickle cell disease allele (HbAA genotype)

    Procedure: Blood sampling

Interventions

  • ProcedureBlood sampling

    Extra blood samples taken for laboratory analysis

06

What researchers measure

Primary outcomes

  1. Hemoglobin level -patient

    Hemoglobin level (g/dL)

    Time frame: 1 hour before blood transfusion

  2. Hemoglobin level -patient

    Hemoglobin level (g/dL)

    Time frame: 1 hour after blood transfusion

  3. % of 'S' type hemoglobin -patient

    % of 'S' type hemoglobin (assessed by means of hemoglobin electrophorese)

    Time frame: 1 hour before blood transfusion

  4. % of 'S' type hemoglobin -patient

    % of 'S' type hemoglobin (assessed by means of hemoglobin electrophorese)

    Time frame: 1 hour after blood transfusion

  5. Hemoglobin level - transfused blood

    Hemoglobin level (g/dL)

    Time frame: 1 hour before blood transfusion

  6. % of 'S' type hemoglobin -transfused blood

    % of 'S' type hemoglobin (assessed by means of hemoglobin electrophorese)

    Time frame: 1 hour before blood transfusion

  7. Transfusion yield

    Computed by means of a formula taking the level of hemoglobin, the % of 'S' type hemoglobin and the body surface into account.

    Time frame: 1 hour after blood transfusion

  8. Medical complications

    List of medical complications having occured after a surgery. Applicable only to the 'transfusion prior to surgery' groups.

    Time frame: 1 month

  9. Length of stay

    Length of stay within the hospital. Applicable only to the 'acute transfusion' groups

    Time frame: 1 month

  10. Length of stay post transfusion

    Length of stay within the hospital after a blood transfusion. Applicable only to the 'acute transfusion' groups

    Time frame: 1 month

  11. Number of blood transfusions

    Number of blood transfusions. Applicable only to the 'acute transfusion' groups

    Time frame: 1 month

  12. Hospital re-admission

    Hospital re-admission. Applicable only to the 'acute transfusion' groups

    Time frame: 1 month

  13. Mortality rate

    Mortality rate. Applicable only to the 'acute transfusion' groups

    Time frame: 1 month.

07

Study locations

2 sites
  • CHU Brugmann
    Brussels, 1020, Belgium
  • HUDERF
    Brussel, 1020, Belgium
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

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

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

Registered
Jan 15, 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 ↗
10

Registry details

Key details

Study ID
NCT03405688
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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