Sickle Cell DiseaseNCT03405402
Transfusion in Sickle Cell Disease: Risk Factors for Alloimmunization
A study testing Blood sampling in people with Sickle Cell Disease, run by Hanane EL KENZ at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Blood sampling
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 2 sitesBelgium
- Study dates
- 13 Feb 2018to 3 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Sickle cell disease patients treated within the CHU Brugmann or Queen Fabiola Children's Hospital
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
About this study
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
- Sickle Cell Disease
- Being tested
- Blood sampling
- Keywords
- Sickle cell disease, Allo-immunization, Blood transfusion
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
Extra blood sampling at the time of a blood transfusion in order to perform the laboratory analysis
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Allo-immunization detected (positive response for irregular antibodies 2 to 4 weeks after a blood transfusion) Receives: Procedure: Blood sampling |
| Control group | Other | Allo-immunization not detected Receives: Procedure: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Irregular antibodies
Presence/abscence of irregular antibodies
Measured: 1 hour before blood transfusion
Irregular antibodies
Presence/abscence of irregular antibodies
Measured: Between 2 to 4 weeks after blood transfusion
C-reactive protein (CRP)
CRP dosage
Measured: 1 hour before blood transfusion
Cytokine
Cytokine dosage
Measured: 1 hour before blood transfusion
Cytokine
Cytokine dosage
Measured: Between 2 to 4 weeks after blood transfusion
Heme oxygenase
Heme oxygenase dosage
Measured: 1 hour before blood transfusion
Heme oxygenase
Heme oxygenase dosage
Measured: Between 2 to 4 weeks after blood transfusion
Lymphocyte typing
Lymphocyte typing
Measured: 1 hour before blood transfusion
Lymphocyte typing
Lymphocyte typing
Measured: Between 2 to 4 weeks after blood transfusion
Secondary outcomes (4)
Sex
Sex
Measured: 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).
Measured: 1 hour before blood transfusion
Blood transfusion indication
Medical reason explaining the necessity of a blood transfusion
Measured: 1 hour before blood transfusion
Blood donor ethnicity
Blood donor ethnicity
Measured: 1 hour before blood transfusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start13 Feb 2018
- Primary completion3 Aug 2020
- Study completion3 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanane EL KENZ
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hanane EL KENZ, Brugmann University Hospital
- Investigators
- Marie Deleers, Ph Biol, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405402
- Sponsor's protocol ID
- CHUB-PRO-TRANSFU-DREPANO 1
- Status last verified
- Jan 2021
- First submitted
- 12 Jan 2018
- Last updated
- 28 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfusion in Sickle Cell Disease: Risk Factors for Alloimmunization
- ClinicalTrials.gov ID
- NCT03405402
- Acronym / sponsor ID
- CHUB-PRO-TRANSFU-DREPANO 1
- Conditions
- Sickle Cell Disease
- Keywords
- Sickle cell disease, Allo-immunization, Blood transfusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Hanane EL KENZUniversity, hospital or other
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- 3 Aug 2020 (actual)
- Study completion
- 3 Aug 2020 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Blood samplingAllo-immunization detected (positive response for irregular antibodies 2 to 4 weeks after a blood transfusion) |
| Control group | Other | Procedure: Blood samplingAllo-immunization not detected |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Sickle cell disease patients treated within the CHU Brugmann or Queen Fabiola Children's Hospital
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingExtra blood sampling at the time of a blood transfusion in order to perform the laboratory analysis | Procedure or surgery | Control group, Experimental group |
Primary outcome
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
4 secondary outcomes
Sex
Time frame: 1 hour before blood transfusion
Chronic or acute blood transfusion
Time frame: 1 hour before blood transfusion
Blood transfusion indication
Time frame: 1 hour before blood transfusion
Blood donor ethnicity
Time frame: 1 hour before blood transfusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Deleers, Ph Biol principal investigator
CHU Brugmann
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Sickle Cell Disease, run by Hanane EL KENZ at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Irregular antibodies (time frame: 1 hour before blood transfusion). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.