Back to resultsTransfusion in Sickle Cell Disease: Screening of Sickle Cell Disease Trait in Blood Donors
Primary Purpose
Sickle Cell Disease, Sickle Cell Trait
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Blood sampling
Sponsored by
About this trial
This is an interventional diagnostic trial for Sickle Cell Disease focused on measuring Sickle cell, Heterozygous, Blood donor
Eligibility Criteria
Inclusion Criteria:
All patients with sickle cell disease within the CHU Brugmann and the Queen Fabiola Children's Hospital (HUDERF)
Exclusion Criteria:
None
Sites / Locations
- CHU Brugmann
- HUDERF
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Other
Experimental
Other
Experimental
Other
Arm Label
Acute transfusion
Control - Acute transfusion
Chronic transfusion
Control - Chronic transfusion
Transfusion prior to surgery
Control - Transfusion prior to surgery
Arm Description
Blood donor heterozygous for the sickle cell disease allele (HbAS genotype)
Blood donor not bearer of the sickle cell disease allele (HbAA genotype)
Blood donor heterozygous for the sickle cell disease allele (HbAS genotype)
Blood donor not bearer of the sickle cell disease allele (HbAA genotype)
Blood donor heterozygous for the sickle cell disease allele (HbAS genotype)
Blood donor not bearer of the sickle cell disease allele (HbAA genotype)
Outcomes
Primary Outcome Measures
Hemoglobin level -patient
Hemoglobin level (g/dL)
Hemoglobin level -patient
Hemoglobin level (g/dL)
% of 'S' type hemoglobin -patient
% of 'S' type hemoglobin (assessed by means of hemoglobin electrophorese)
% of 'S' type hemoglobin -patient
% of 'S' type hemoglobin (assessed by means of hemoglobin electrophorese)
Hemoglobin level - transfused blood
Hemoglobin level (g/dL)
% of 'S' type hemoglobin -transfused blood
% of 'S' type hemoglobin (assessed by means of hemoglobin electrophorese)
Transfusion yield
Computed by means of a formula taking the level of hemoglobin, the % of 'S' type hemoglobin and the body surface into account.
Medical complications
List of medical complications having occured after a surgery. Applicable only to the 'transfusion prior to surgery' groups.
Length of stay
Length of stay within the hospital. Applicable only to the 'acute transfusion' groups
Length of stay post transfusion
Length of stay within the hospital after a blood transfusion. Applicable only to the 'acute transfusion' groups
Number of blood transfusions
Number of blood transfusions. Applicable only to the 'acute transfusion' groups
Hospital re-admission
Hospital re-admission. Applicable only to the 'acute transfusion' groups
Mortality rate
Mortality rate. Applicable only to the 'acute transfusion' groups
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03405688
Brief Title
Transfusion in Sickle Cell Disease: Screening of Sickle Cell Disease Trait in Blood Donors
Official Title
Transfusion in Sickle Cell Disease: Screening of Sickle Cell Disease Trait in Blood Donors
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
February 13, 2018 (Actual)
Primary Completion Date
August 3, 2020 (Actual)
Study Completion Date
August 3, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hanane EL KENZ
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease, Sickle Cell Trait
Keywords
Sickle cell, Heterozygous, Blood donor
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
173 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acute transfusion
Arm Type
Experimental
Arm Description
Blood donor heterozygous for the sickle cell disease allele (HbAS genotype)
Arm Title
Control - Acute transfusion
Arm Type
Other
Arm Description
Blood donor not bearer of the sickle cell disease allele (HbAA genotype)
Arm Title
Chronic transfusion
Arm Type
Experimental
Arm Description
Blood donor heterozygous for the sickle cell disease allele (HbAS genotype)
Arm Title
Control - Chronic transfusion
Arm Type
Other
Arm Description
Blood donor not bearer of the sickle cell disease allele (HbAA genotype)
Arm Title
Transfusion prior to surgery
Arm Type
Experimental
Arm Description
Blood donor heterozygous for the sickle cell disease allele (HbAS genotype)
Arm Title
Control - Transfusion prior to surgery
Arm Type
Other
Arm Description
Blood donor not bearer of the sickle cell disease allele (HbAA genotype)
Intervention Type
Procedure
Intervention Name(s)
Blood sampling
Intervention Description
Extra blood samples taken for laboratory analysis
Primary Outcome Measure Information:
Title
Hemoglobin level -patient
Description
Hemoglobin level (g/dL)
Time Frame
1 hour before blood transfusion
Title
Hemoglobin level -patient
Description
Hemoglobin level (g/dL)
Time Frame
1 hour after blood transfusion
Title
% of 'S' type hemoglobin -patient
Description
% of 'S' type hemoglobin (assessed by means of hemoglobin electrophorese)
Time Frame
1 hour before blood transfusion
Title
% of 'S' type hemoglobin -patient
Description
% of 'S' type hemoglobin (assessed by means of hemoglobin electrophorese)
Time Frame
1 hour after blood transfusion
Title
Hemoglobin level - transfused blood
Description
Hemoglobin level (g/dL)
Time Frame
1 hour before blood transfusion
Title
% of 'S' type hemoglobin -transfused blood
Description
% of 'S' type hemoglobin (assessed by means of hemoglobin electrophorese)
Time Frame
1 hour before blood transfusion
Title
Transfusion yield
Description
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
Title
Medical complications
Description
List of medical complications having occured after a surgery. Applicable only to the 'transfusion prior to surgery' groups.
Time Frame
1 month
Title
Length of stay
Description
Length of stay within the hospital. Applicable only to the 'acute transfusion' groups
Time Frame
1 month
Title
Length of stay post transfusion
Description
Length of stay within the hospital after a blood transfusion. Applicable only to the 'acute transfusion' groups
Time Frame
1 month
Title
Number of blood transfusions
Description
Number of blood transfusions. Applicable only to the 'acute transfusion' groups
Time Frame
1 month
Title
Hospital re-admission
Description
Hospital re-admission. Applicable only to the 'acute transfusion' groups
Time Frame
1 month
Title
Mortality rate
Description
Mortality rate. Applicable only to the 'acute transfusion' groups
Time Frame
1 month.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients with sickle cell disease within the CHU Brugmann and the Queen Fabiola Children's Hospital (HUDERF)
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Deleers, Ph Biol
Organizational Affiliation
CHU Brugmann
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Brugmann
City
Brussels
ZIP/Postal Code
1020
Country
Belgium
Facility Name
HUDERF
City
Brussel
ZIP/Postal Code
1020
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Transfusion in Sickle Cell Disease: Screening of Sickle Cell Disease Trait in Blood Donors
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