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

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ClinicalTrials.gov Identifier: NCT03405688
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Hanane EL KENZ, Brugmann University Hospital

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020


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




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



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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:


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


Contacts
Contact: Marie Deleers, Ph Biol 3224772409 marie.deleers@chu-brugmann.be
Contact: Hanane El Kenz, Ph Biol 3224772734 hanane.elkenz@chu-brugmann.be

Locations
Belgium
CHU Brugmann Recruiting
Brussels, Belgium, 1020
Contact: Marie Deleers, Ph Biol    + 32 2 477 24 09    marie.deleers@chu-brugmann.be   
HUDERF Recruiting
Brussel, Belgium, 1020
Contact: Marie Deleers, Ph Biol    + 32 2 477 24 09    marie.deleers@chu-brugmann.be   
Sponsors and Collaborators
Hanane EL KENZ
Investigators
Principal Investigator: Marie Deleers, Ph Biol CHU Brugmann

Responsible Party: Hanane EL KENZ, Head of Blood Bank, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT03405688     History of Changes
Other Study ID Numbers: CHUB-PRO-TRANSFU-DREPANO 2
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
Anemia, Sickle Cell
Sickle Cell Trait
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn