- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03405688
Transfusion in Sickle Cell Disease: Screening of Sickle Cell Disease Trait in Blood Donors
January 27, 2021 updated by: Hanane EL KENZ
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
173
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Brussel, Belgium, 1020
- Huderf
-
Brussels, Belgium, 1020
- CHU Brugmann
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
All patients with sickle cell disease within the CHU Brugmann and the Queen Fabiola Children's Hospital (HUDERF)
Exclusion Criteria:
None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acute transfusion
Blood donor heterozygous for the sickle cell disease allele (HbAS genotype)
|
Extra blood samples taken for laboratory analysis
|
Other: Control - Acute transfusion
Blood donor not bearer of the sickle cell disease allele (HbAA genotype)
|
Extra blood samples taken for laboratory analysis
|
Experimental: Chronic transfusion
Blood donor heterozygous for the sickle cell disease allele (HbAS genotype)
|
Extra blood samples taken for laboratory analysis
|
Other: Control - Chronic transfusion
Blood donor not bearer of the sickle cell disease allele (HbAA genotype)
|
Extra blood samples taken for laboratory analysis
|
Experimental: Transfusion prior to surgery
Blood donor heterozygous for the sickle cell disease allele (HbAS genotype)
|
Extra blood samples taken for laboratory analysis
|
Other: Control - Transfusion prior to surgery
Blood donor not bearer of the sickle cell disease allele (HbAA genotype)
|
Extra blood samples taken for laboratory analysis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemoglobin level -patient
Time Frame: 1 hour before blood transfusion
|
Hemoglobin level (g/dL)
|
1 hour before blood transfusion
|
Hemoglobin level -patient
Time Frame: 1 hour after blood transfusion
|
Hemoglobin level (g/dL)
|
1 hour after blood transfusion
|
% of 'S' type hemoglobin -patient
Time Frame: 1 hour before blood transfusion
|
% of 'S' type hemoglobin (assessed by means of hemoglobin electrophorese)
|
1 hour before blood transfusion
|
% of 'S' type hemoglobin -patient
Time Frame: 1 hour after blood transfusion
|
% of 'S' type hemoglobin (assessed by means of hemoglobin electrophorese)
|
1 hour after blood transfusion
|
Hemoglobin level - transfused blood
Time Frame: 1 hour before blood transfusion
|
Hemoglobin level (g/dL)
|
1 hour before blood transfusion
|
% of 'S' type hemoglobin -transfused blood
Time Frame: 1 hour before blood transfusion
|
% of 'S' type hemoglobin (assessed by means of hemoglobin electrophorese)
|
1 hour before blood transfusion
|
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.
|
1 hour after blood transfusion
|
Medical complications
Time Frame: 1 month
|
List of medical complications having occured after a surgery.
Applicable only to the 'transfusion prior to surgery' groups.
|
1 month
|
Length of stay
Time Frame: 1 month
|
Length of stay within the hospital.
Applicable only to the 'acute transfusion' groups
|
1 month
|
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
|
1 month
|
Number of blood transfusions
Time Frame: 1 month
|
Number of blood transfusions.
Applicable only to the 'acute transfusion' groups
|
1 month
|
Hospital re-admission
Time Frame: 1 month
|
Hospital re-admission.
Applicable only to the 'acute transfusion' groups
|
1 month
|
Mortality rate
Time Frame: 1 month.
|
Mortality rate.
Applicable only to the 'acute transfusion' groups
|
1 month.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marie Deleers, Ph Biol, CHU Brugmann
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 13, 2018
Primary Completion (Actual)
August 3, 2020
Study Completion (Actual)
August 3, 2020
Study Registration Dates
First Submitted
January 15, 2018
First Submitted That Met QC Criteria
January 15, 2018
First Posted (Actual)
January 23, 2018
Study Record Updates
Last Update Posted (Actual)
January 28, 2021
Last Update Submitted That Met QC Criteria
January 27, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUB-PRO-TRANSFU-DREPANO 2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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