We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Transfusion in Sickle Cell Disease: Screening of Sickle Cell Disease Trait in Blood Donors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03405688
Recruitment Status : Completed
First Posted : January 23, 2018
Last Update Posted : January 28, 2021
Sponsor:
Information provided by (Responsible Party):
Hanane EL KENZ, Brugmann University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Sickle Cell Trait Procedure: Blood sampling Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 173 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Transfusion in Sickle Cell Disease: Screening of Sickle Cell Disease Trait in Blood Donors
Actual Study Start Date : February 13, 2018
Actual Primary Completion Date : August 3, 2020
Actual Study Completion Date : August 3, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Acute transfusion
Blood donor heterozygous for the sickle cell disease allele (HbAS genotype)
 Procedure: Blood sampling
Extra blood samples taken for laboratory analysis
Control - Acute transfusion
Blood donor not bearer of the sickle cell disease allele (HbAA genotype)
 Procedure: Blood sampling
Extra blood samples taken for laboratory analysis
Experimental: Chronic transfusion
Blood donor heterozygous for the sickle cell disease allele (HbAS genotype)
 Procedure: Blood sampling
Extra blood samples taken for laboratory analysis
Control - Chronic transfusion
Blood donor not bearer of the sickle cell disease allele (HbAA genotype)
 Procedure: Blood sampling
Extra blood samples taken for laboratory analysis
Experimental: Transfusion prior to surgery
Blood donor heterozygous for the sickle cell disease allele (HbAS genotype)
 Procedure: Blood sampling
Extra blood samples taken for laboratory analysis
Control - Transfusion prior to surgery
Blood donor not bearer of the sickle cell disease allele (HbAA genotype)
 Procedure: Blood sampling
Extra blood samples taken for laboratory analysis


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Hemoglobin level -patient [ Time Frame: 1 hour before blood transfusion ]
    Hemoglobin level (g/dL)

  2. Hemoglobin level -patient [ Time Frame: 1 hour after blood transfusion ]
    Hemoglobin level (g/dL)

  3. % of 'S' type hemoglobin -patient [ Time Frame: 1 hour before blood transfusion ]
    % of 'S' type hemoglobin (assessed by means of hemoglobin electrophorese)

  4. % of 'S' type hemoglobin -patient [ Time Frame: 1 hour after blood transfusion ]
    % of 'S' type hemoglobin (assessed by means of hemoglobin electrophorese)

  5. Hemoglobin level - transfused blood [ Time Frame: 1 hour before blood transfusion ]
    Hemoglobin level (g/dL)

  6. % of 'S' type hemoglobin -transfused blood [ Time Frame: 1 hour before blood transfusion ]
    % of 'S' type hemoglobin (assessed by means of hemoglobin electrophorese)

  7. 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.

  8. Medical complications [ Time Frame: 1 month ]
    List of medical complications having occured after a surgery. Applicable only to the 'transfusion prior to surgery' groups.

  9. Length of stay [ Time Frame: 1 month ]
    Length of stay within the hospital. Applicable only to the 'acute transfusion' groups

  10. 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

  11. Number of blood transfusions [ Time Frame: 1 month ]
    Number of blood transfusions. Applicable only to the 'acute transfusion' groups

  12. Hospital re-admission [ Time Frame: 1 month ]
    Hospital re-admission. Applicable only to the 'acute transfusion' groups

  13. Mortality rate [ Time Frame: 1 month. ]
    Mortality rate. Applicable only to the 'acute transfusion' groups


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All patients with sickle cell disease within the CHU Brugmann and the Queen Fabiola Children's Hospital (HUDERF)

Exclusion Criteria:

None

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03405688


Locations
Layout table for location information
Belgium
CHU Brugmann
Brussels, Belgium, 1020
HUDERF
Brussel, Belgium, 1020
Sponsors and Collaborators
Hanane EL KENZ
Investigators
Layout table for investigator information
Principal Investigator: Marie Deleers, Ph Biol CHU Brugmann
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Hanane EL KENZ, Head of Blood Bank, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT03405688    
Other Study ID Numbers: CHUB-PRO-TRANSFU-DREPANO 2
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: January 28, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hanane EL KENZ, Brugmann University Hospital:
Sickle cell
Heterozygous
Blood donor
Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia, Sickle Cell
Sickle Cell Trait
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
 Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn