Transfusion in Sickle Cell Disease: Risk Factors for Alloimmunization

Sickle Cell Disease Clinical Trial

Official title:

Transfusion in Sickle Cell Disease: Risk Factors for Alloimmunization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03405402
• Other study ID #: CHUB-PRO-TRANSFU-DREPANO 1
• Status: Completed
• Phase: N/A
• Start date: February 13, 2018
• Est. completion date: August 3, 2020

Study information

• Verified date: January 2021
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Sickle cell patients have a high prevalence of alloimmunization. This high rate of alloimmunization can be partially explained by the existence of an antigenic difference between the predominantly Caucasian donor population and the sickle cell patients of African origin. Genetic and environmental risk factors have also been described.

The main risk factors that have been shown in retrospective or cross-sectional studies are some HLA alleles, the age of the patient, the number of leukocyte-depleted erythrocyte concentrates (CED) transfused, the number of transfusion episodes, the age of the CEDs, the existence of an inflammatory event at the time of transfusion and the presence of anti-erythrocyte autoantibodies.There is also evidence of an impaired TH response but the underlying immunological mechanism is not fully understood.

The aim of this study is to study the prevalence and the risk factors for anti-erythrocyte alloimmunization and to try to understand the immunological mechanisms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: August 3, 2020
• Est. primary completion date: August 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Sickle cell disease patients treated within the CHU Brugmann or Queen Fabiola Children's Hospital

Exclusion Criteria:

None

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Procedure:
• Blood sampling
Extra blood sampling at the time of a blood transfusion in order to perform the laboratory analysis

Locations

Country	Name	City	State
Belgium	HUDERF	Brussel
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Hanane EL KENZ

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Irregular antibodies	Presence/abscence of irregular antibodies	1 hour before blood transfusion
Primary	Irregular antibodies	Presence/abscence of irregular antibodies	Between 2 to 4 weeks after blood transfusion
Primary	C-reactive protein (CRP)	CRP dosage	1 hour before blood transfusion
Primary	Cytokine	Cytokine dosage	1 hour before blood transfusion
Primary	Cytokine	Cytokine dosage	Between 2 to 4 weeks after blood transfusion
Primary	Heme oxygenase	Heme oxygenase dosage	1 hour before blood transfusion
Primary	Heme oxygenase	Heme oxygenase dosage	Between 2 to 4 weeks after blood transfusion
Primary	Lymphocyte typing	Lymphocyte typing	1 hour before blood transfusion
Primary	Lymphocyte typing	Lymphocyte typing	Between 2 to 4 weeks after blood transfusion
Secondary	Sex	Sex	1 hour before blood transfusion
Secondary	Chronic or acute blood transfusion	Blood transfusions planned at regular intervals of time (chronic transfusions) or performed in reaction to a medical issue (acute transfusion).	1 hour before blood transfusion
Secondary	Blood transfusion indication	Medical reason explaining the necessity of a blood transfusion	1 hour before blood transfusion
Secondary	Blood donor ethnicity	Blood donor ethnicity	1 hour before blood transfusion