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NCT Number: NCT03405688

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

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.

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Sickle Cell Trait

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Brugmann, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

None

Treatment and study plan

blood sampling

Procedure

Extra blood samples taken for laboratory analysis

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hanane EL KENZ

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 23, 2018
Registry last updated
Jan 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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