NCT03405688

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
173

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

February 13, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2020

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

2.5 years

First QC Date

January 15, 2018

Last Update Submit

January 27, 2021

Conditions

Sickle Cell DiseaseSickle Cell Trait

Keywords

Sickle cellHeterozygousBlood donor

Outcome Measures

Primary Outcomes (13)

  • Hemoglobin level -patient

    Hemoglobin level (g/dL)

    1 hour before blood transfusion

  • Hemoglobin level -patient

    Hemoglobin level (g/dL)

    1 hour after blood transfusion

  • % of 'S' type hemoglobin -patient

    % of 'S' type hemoglobin (assessed by means of hemoglobin electrophorese)

    1 hour before blood transfusion

  • % of 'S' type hemoglobin -patient

    % of 'S' type hemoglobin (assessed by means of hemoglobin electrophorese)

    1 hour after blood transfusion

  • Hemoglobin level - transfused blood

    Hemoglobin level (g/dL)

    1 hour before blood transfusion

  • % of 'S' type hemoglobin -transfused blood

    % of 'S' type hemoglobin (assessed by means of hemoglobin electrophorese)

    1 hour before blood transfusion

  • Transfusion yield

    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

    List of medical complications having occured after a surgery. Applicable only to the 'transfusion prior to surgery' groups.

    1 month

  • Length of stay

    Length of stay within the hospital. Applicable only to the 'acute transfusion' groups

    1 month

  • Length of stay post transfusion

    Length of stay within the hospital after a blood transfusion. Applicable only to the 'acute transfusion' groups

    1 month

  • Number of blood transfusions

    Number of blood transfusions. Applicable only to the 'acute transfusion' groups

    1 month

  • Hospital re-admission

    Hospital re-admission. Applicable only to the 'acute transfusion' groups

    1 month

  • Mortality rate

    Mortality rate. Applicable only to the 'acute transfusion' groups

    1 month.

Study Arms (6)

Acute transfusion

EXPERIMENTAL

Blood donor heterozygous for the sickle cell disease allele (HbAS genotype)

Procedure: Blood sampling

Control - Acute transfusion

OTHER

Blood donor not bearer of the sickle cell disease allele (HbAA genotype)

Procedure: Blood sampling

Chronic transfusion

EXPERIMENTAL

Blood donor heterozygous for the sickle cell disease allele (HbAS genotype)

Procedure: Blood sampling

Control - Chronic transfusion

OTHER

Blood donor not bearer of the sickle cell disease allele (HbAA genotype)

Procedure: Blood sampling

Transfusion prior to surgery

EXPERIMENTAL

Blood donor heterozygous for the sickle cell disease allele (HbAS genotype)

Procedure: Blood sampling

Control - Transfusion prior to surgery

OTHER

Blood donor not bearer of the sickle cell disease allele (HbAA genotype)

Procedure: Blood sampling

Interventions

Blood samplingPROCEDURE

Extra blood samples taken for laboratory analysis

Acute transfusionChronic transfusionControl - Acute transfusionControl - Chronic transfusionControl - Transfusion prior to surgeryTransfusion prior to surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Brugmann

Brussels, 1020, Belgium

Location

HUDERF

Brussels, 1020, Belgium

Location

MeSH Terms

Conditions

Anemia, Sickle CellSickle Cell Trait

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Marie Deleers, Ph Biol

    CHU Brugmann

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Blood Bank

Study Record Dates

First Submitted

January 15, 2018

First Posted

January 23, 2018

Study Start

February 13, 2018

Primary Completion

August 3, 2020

Study Completion

August 3, 2020

Last Updated

January 28, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

BE(2)