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

January 27, 2021 updated by: Hanane EL KENZ
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.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

173

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Brussel, Belgium, 1020
        • Huderf
      • Brussels, Belgium, 1020
        • CHU Brugmann

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin level -patient
Time Frame: 1 hour before blood transfusion
Hemoglobin level (g/dL)
1 hour before blood transfusion
Hemoglobin level -patient
Time Frame: 1 hour after blood transfusion
Hemoglobin level (g/dL)
1 hour after blood transfusion
% of 'S' type hemoglobin -patient
Time Frame: 1 hour before blood transfusion
% of 'S' type hemoglobin (assessed by means of hemoglobin electrophorese)
1 hour before blood transfusion
% of 'S' type hemoglobin -patient
Time Frame: 1 hour after blood transfusion
% of 'S' type hemoglobin (assessed by means of hemoglobin electrophorese)
1 hour after blood transfusion
Hemoglobin level - transfused blood
Time Frame: 1 hour before blood transfusion
Hemoglobin level (g/dL)
1 hour before blood transfusion
% of 'S' type hemoglobin -transfused blood
Time Frame: 1 hour before blood transfusion
% of 'S' type hemoglobin (assessed by means of hemoglobin electrophorese)
1 hour before blood transfusion
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.
1 hour after blood transfusion
Medical complications
Time Frame: 1 month
List of medical complications having occured after a surgery. Applicable only to the 'transfusion prior to surgery' groups.
1 month
Length of stay
Time Frame: 1 month
Length of stay within the hospital. Applicable only to the 'acute transfusion' groups
1 month
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
1 month
Number of blood transfusions
Time Frame: 1 month
Number of blood transfusions. Applicable only to the 'acute transfusion' groups
1 month
Hospital re-admission
Time Frame: 1 month
Hospital re-admission. Applicable only to the 'acute transfusion' groups
1 month
Mortality rate
Time Frame: 1 month.
Mortality rate. Applicable only to the 'acute transfusion' groups
1 month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Marie Deleers, Ph Biol, CHU Brugmann

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2018

Primary Completion (Actual)

August 3, 2020

Study Completion (Actual)

August 3, 2020

Study Registration Dates

First Submitted

January 15, 2018

First Submitted That Met QC Criteria

January 15, 2018

First Posted (Actual)

January 23, 2018

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 27, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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