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

Not Applicable

Completed

• Conditions: Sickle Cell Trait; Sickle Cell Disease
• Interventions: Procedure: Blood sampling

• Registration Number: NCT03405688
• Lead Sponsor: Hanane EL KENZ

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-15
• Study First Submitted QC: 2018-01-15
• Study First Posted: 2018-01-23
• Study Start: 2018-02-13
• Primary Completion: 2020-08-03
• Study Completion: 2020-08-03
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

Inclusion Criteria

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

Exclusion Criteria

None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control - Transfusion prior to surgery	Blood sampling	Blood donor not bearer of the sickle cell disease allele (HbAA genotype)
Control - Acute transfusion	Blood sampling	Blood donor not bearer of the sickle cell disease allele (HbAA genotype)
Acute transfusion	Blood sampling	Blood donor heterozygous for the sickle cell disease allele (HbAS genotype)
Chronic transfusion	Blood sampling	Blood donor heterozygous for the sickle cell disease allele (HbAS genotype)
Transfusion prior to surgery	Blood sampling	Blood donor heterozygous for the sickle cell disease allele (HbAS genotype)
Control - Chronic transfusion	Blood sampling	Blood donor not bearer of the sickle cell disease allele (HbAA genotype)

Primary Outcome Measures

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

Trial Locations

Locations (2)

CHU Brugmann; 🇧🇪 Brussels, Belgium

HUDERF; 🇧🇪 Brussel, Belgium