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

Study Overview
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Brief Summary
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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.

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

Conditions
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Sickle Cell Disease, Sickle Cell Trait

Intervention / Treatment
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* Procedure: Blood sampling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with sickle cell disease within the CHU Brugmann and the Queen Fabiola Children's Hospital (HUDERF) Exclusion Criteria: None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sickle cell, Heterozygous, Blood donor