Sickle Cell DiseaseNCT03401125
Risk Factors for Allo-immunization in Sickle Cell Disease
An observational study of 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?
- Medical file data collection
- How many people
- 0 participants
- Where
- 2 sitesBelgium
- Study dates
- 1 Feb 2018to 1 Jul 2018
- Phase
- Observational
- 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
Study population: Sickle cell disease patients (HbSS genotype) with a history of blood transfusion within the CHU Brugmann and the Queen Fabiola University Hospitals.
Who may be able to join
- Sickle cell disease patients (HbSS genotype) with a history of blood transfusions within the CHU Brugmann and the Queen Fabiola University Hospitals.
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Retrospective Study of the Risk Factors for Allo-immunization in Sickle Cell Disease
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 in pediatric and adult patients with Sickle Cell Disease (with a SS genotype) who are being followed at Queen Fabiola University Children's Hospital (HUDERF) and at the CHU Brugmann Hospital. The identification of risk factors would allow the investigators to improve, or at least adapt, their transfusion policy to certain clinical or immuno-haematological situations.
- Conditions
- Sickle Cell Disease
- Being tested
- Medical file data collection
- Keywords
- Sickle cell disease, Allo-immunization
- 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.
Medical file data collectionOther
The information described in the 'outcome measures' section will be collected from the medical files of the patients.
| Study group | Role | What they receive |
|---|---|---|
| Sickle cell disease patients (SS genotype) | Sickle cell disease patients with a SS genotype having an history of blood transfusions within the CHU Brugmann and the Queen Fabiola Children's Hospitals. Receives: Other: Medical file data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Date of birth
Date of birth
Measured: january 2013-december 2017
Sex
Sex
Measured: january 2013-december 2017
Blood group
Blood group
Measured: january 2013-december 2017
Extended phenotype
Sickle cell disease extended phenotype
Measured: january 2013-december 2017
Antibodies
Presence/absence of irregular anti-erythrocytes antibodies (RAI)
Measured: january 2013-december 2017
Number of blood transfusions
Number of blood transfusions
Measured: january 2013-december 2017
Number of blood transfusions
Number of blood transfusions
Measured: From birth till the first positive RAI test (up to 50 years)
Auto antibodies
Presence/absence of auto anti-erythrocytes antibodies (RAI)
Measured: january 2013-december 2017
Pathology
Medical issue causing the patient to be included in a chronic blood transfusion program
Measured: january 2013-december 2017
Duration of the chronic transfusion program
Duration of the chronic transfusion program
Measured: january 2013-december 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start1 Feb 2018
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Why it stopped: Results already published by another team
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 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
- NCT03401125
- Sponsor's protocol ID
- CHUB-RETRO-ALLO
- Status last verified
- Jul 2018
- First submitted
- 10 Jan 2018
- Last updated
- 26 Jul 2018
- 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 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of the Risk Factors for Allo-immunization in Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT03401125
- Acronym / sponsor ID
- CHUB-RETRO-ALLO
- Conditions
- Sickle Cell Disease
- Keywords
- Sickle cell disease, Allo-immunization
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Results already published by another team
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hanane EL KENZUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 17 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 in pediatric and adult patients with Sickle Cell Disease (with a SS genotype) who are being followed at Queen Fabiola University Children's Hospital (HUDERF) and at the CHU Brugmann Hospital. The identification of risk factors would allow the investigators to improve, or at least adapt, their transfusion policy to certain clinical or immuno-haematological situations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sickle cell disease patients (SS genotype) | – | Other: Medical file data collectionSickle cell disease patients with a SS genotype having an history of blood transfusions within the CHU Brugmann and the Queen Fabiola Children's Hospitals. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Sickle cell disease patients (HbSS genotype) with a history of blood transfusion within the CHU Brugmann and the Queen Fabiola University Hospitals.
Key inclusion criteria (1 listed)
- Sickle cell disease patients (HbSS genotype) with a history of blood transfusions within the CHU Brugmann and the Queen Fabiola University Hospitals.
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 |
|---|---|---|
| Medical file data collectionThe information described in the 'outcome measures' section will be collected from the medical files of the patients. | Other | Sickle cell disease patients (SS genotype) |
Primary outcome
Date of birth
Time frame: january 2013-december 2017
Date of birth
Sex
Time frame: january 2013-december 2017
Sex
Blood group
Time frame: january 2013-december 2017
Blood group
Extended phenotype
Time frame: january 2013-december 2017
Sickle cell disease extended phenotype
Antibodies
Time frame: january 2013-december 2017
Presence/absence of irregular anti-erythrocytes antibodies (RAI)
Number of blood transfusions
Time frame: january 2013-december 2017
Number of blood transfusions
Number of blood transfusions
Time frame: From birth till the first positive RAI test (up to 50 years)
Number of blood transfusions
Auto antibodies
Time frame: january 2013-december 2017
Presence/absence of auto anti-erythrocytes antibodies (RAI)
Pathology
Time frame: january 2013-december 2017
Medical issue causing the patient to be included in a chronic blood transfusion program
Duration of the chronic transfusion program
Time frame: january 2013-december 2017
Duration of the chronic transfusion program
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
- 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?
An observational study of 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: withdrawn, as of the sponsor's last update on 26 Jul 2018. 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 was withdrawn before enrolling participants, so there are no results.
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?
Date of birth (time frame: january 2013-december 2017). The study lists 10 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 26 Jul 2018.