Sickle Cell DiseaseNCT03405688
Transfusion in Sickle Cell Disease: Screening of Sickle Cell Disease Trait in Blood Donors
A study testing Blood sampling in people with Sickle Cell Disease and Sickle Cell Trait, run by Hanane EL KENZ at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sickle Cell Disease, Sickle Cell Trait
- What is being tested?
- Blood sampling
- Type of treatment
- 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
- All patients with sickle cell disease within the CHU Brugmann and the Queen Fabiola Children's Hospital (HUDERF)
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
About this study
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.
- Conditions
- Sickle Cell Disease, Sickle Cell Trait
- Being tested
- Blood sampling
- Keywords
- Sickle cell, Heterozygous, Blood donor
- Medical subject headings
- Anemia, Sickle Cell, Sickle Cell Trait
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 samples taken for laboratory analysis
| Study group | Role | What they receive |
|---|---|---|
| Acute transfusion | Experimental | Blood donor heterozygous for the sickle cell disease allele (HbAS genotype) Receives: Procedure: Blood sampling |
| Control - Acute transfusion | Other | Blood donor not bearer of the sickle cell disease allele (HbAA genotype) Receives: Procedure: Blood sampling |
| Chronic transfusion | Experimental | Blood donor heterozygous for the sickle cell disease allele (HbAS genotype) Receives: Procedure: Blood sampling |
| Control - Chronic transfusion | Other | Blood donor not bearer of the sickle cell disease allele (HbAA genotype) Receives: Procedure: Blood sampling |
| Transfusion prior to surgery | Experimental | Blood donor heterozygous for the sickle cell disease allele (HbAS genotype) Receives: Procedure: Blood sampling |
| Control - Transfusion prior to surgery | Other | Blood donor not bearer of the sickle cell disease allele (HbAA genotype) Receives: Procedure: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin level -patient
Hemoglobin level (g/dL)
Measured: 1 hour before blood transfusion
Hemoglobin level -patient
Hemoglobin level (g/dL)
Measured: 1 hour after blood transfusion
% of 'S' type hemoglobin -patient
% of 'S' type hemoglobin (assessed by means of hemoglobin electrophorese)
Measured: 1 hour before blood transfusion
% of 'S' type hemoglobin -patient
% of 'S' type hemoglobin (assessed by means of hemoglobin electrophorese)
Measured: 1 hour after blood transfusion
Hemoglobin level - transfused blood
Hemoglobin level (g/dL)
Measured: 1 hour before blood transfusion
% of 'S' type hemoglobin -transfused blood
% of 'S' type hemoglobin (assessed by means of hemoglobin electrophorese)
Measured: 1 hour before blood transfusion
Transfusion yield
Computed by means of a formula taking the level of hemoglobin, the % of 'S' type hemoglobin and the body surface into account.
Measured: 1 hour after blood transfusion
Medical complications
List of medical complications having occured after a surgery. Applicable only to the 'transfusion prior to surgery' groups.
Measured: 1 month
Length of stay
Length of stay within the hospital. Applicable only to the 'acute transfusion' groups
Measured: 1 month
Length of stay post transfusion
Length of stay within the hospital after a blood transfusion. Applicable only to the 'acute transfusion' groups
Measured: 1 month
Number of blood transfusions
Number of blood transfusions. Applicable only to the 'acute transfusion' groups
Measured: 1 month
Hospital re-admission
Hospital re-admission. Applicable only to the 'acute transfusion' groups
Measured: 1 month
Mortality rate
Mortality rate. Applicable only to the 'acute transfusion' groups
Measured: 1 month.
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
- Diagnosis
- 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
- NCT03405688
- Sponsor's protocol ID
- CHUB-PRO-TRANSFU-DREPANO 2
- Status last verified
- Jan 2021
- First submitted
- 15 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: Screening of Sickle Cell Disease Trait in Blood Donors
- ClinicalTrials.gov ID
- NCT03405688
- Acronym / sponsor ID
- CHUB-PRO-TRANSFU-DREPANO 2
- Conditions
- Sickle Cell Disease, Sickle Cell Trait
- Keywords
- Sickle cell, Heterozygous, Blood donor
- 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Acute transfusion | Experimental | Procedure: Blood samplingBlood donor heterozygous for the sickle cell disease allele (HbAS genotype) |
| Control - Acute transfusion | Other | Procedure: Blood samplingBlood donor not bearer of the sickle cell disease allele (HbAA genotype) |
| Chronic transfusion | Experimental | Procedure: Blood samplingBlood donor heterozygous for the sickle cell disease allele (HbAS genotype) |
| Control - Chronic transfusion | Other | Procedure: Blood samplingBlood donor not bearer of the sickle cell disease allele (HbAA genotype) |
| Transfusion prior to surgery | Experimental | Procedure: Blood samplingBlood donor heterozygous for the sickle cell disease allele (HbAS genotype) |
| Control - Transfusion prior to surgery | Other | Procedure: Blood samplingBlood donor not bearer of the sickle cell disease allele (HbAA genotype) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with sickle cell disease within the CHU Brugmann and the Queen Fabiola Children's Hospital (HUDERF)
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 samples taken for laboratory analysis | Procedure or surgery | Acute transfusion, Chronic transfusion, Control - Acute transfusion, Control - Chronic transfusion, Control - Transfusion prior to surgery, Transfusion prior to surgery |
Primary outcome
Hemoglobin level -patient
Time frame: 1 hour before blood transfusion
Hemoglobin level (g/dL)
Hemoglobin level -patient
Time frame: 1 hour after blood transfusion
Hemoglobin level (g/dL)
% of 'S' type hemoglobin -patient
Time frame: 1 hour before blood transfusion
% of 'S' type hemoglobin (assessed by means of hemoglobin electrophorese)
% of 'S' type hemoglobin -patient
Time frame: 1 hour after blood transfusion
% of 'S' type hemoglobin (assessed by means of hemoglobin electrophorese)
Hemoglobin level - transfused blood
Time frame: 1 hour before blood transfusion
Hemoglobin level (g/dL)
% of 'S' type hemoglobin -transfused blood
Time frame: 1 hour before blood transfusion
% of 'S' type hemoglobin (assessed by means of hemoglobin electrophorese)
Transfusion yield
Time frame: 1 hour after blood transfusion
Computed by means of a formula taking the level of hemoglobin, the % of 'S' type hemoglobin and the body surface into account.
Medical complications
Time frame: 1 month
List of medical complications having occured after a surgery. Applicable only to the 'transfusion prior to surgery' groups.
Length of stay
Time frame: 1 month
Length of stay within the hospital. Applicable only to the 'acute transfusion' groups
Length of stay post transfusion
Time frame: 1 month
Length of stay within the hospital after a blood transfusion. Applicable only to the 'acute transfusion' groups
Number of blood transfusions
Time frame: 1 month
Number of blood transfusions. Applicable only to the 'acute transfusion' groups
Hospital re-admission
Time frame: 1 month
Hospital re-admission. Applicable only to the 'acute transfusion' groups
Mortality rate
Time frame: 1 month.
Mortality rate. Applicable only to the 'acute transfusion' groups
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 and Sickle Cell Trait, 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?
Hemoglobin level -patient (time frame: 1 hour before blood transfusion). The study lists 13 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.