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

Sickle Cell Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03405688
• Other study ID #: CHUB-PRO-TRANSFU-DREPANO 2
• 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

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.

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:

All patients with sickle cell disease within the CHU Brugmann and the Queen Fabiola Children's Hospital (HUDERF) Exclusion Criteria: None

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease
• Sickle Cell Trait

Intervention

Procedure:
• Blood sampling
Extra blood samples taken for 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	Hemoglobin level -patient	Hemoglobin level (g/dL)	1 hour before blood transfusion
Primary	Hemoglobin level -patient	Hemoglobin level (g/dL)	1 hour after blood transfusion
Primary	% of 'S' type hemoglobin -patient	% of 'S' type hemoglobin (assessed by means of hemoglobin electrophorese)	1 hour before blood transfusion
Primary	% of 'S' type hemoglobin -patient	% of 'S' type hemoglobin (assessed by means of hemoglobin electrophorese)	1 hour after blood transfusion
Primary	Hemoglobin level - transfused blood	Hemoglobin level (g/dL)	1 hour before blood transfusion
Primary	% of 'S' type hemoglobin -transfused blood	% of 'S' type hemoglobin (assessed by means of hemoglobin electrophorese)	1 hour before blood transfusion
Primary	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
Primary	Medical complications	List of medical complications having occured after a surgery. Applicable only to the 'transfusion prior to surgery' groups.	1 month
Primary	Length of stay	Length of stay within the hospital. Applicable only to the 'acute transfusion' groups	1 month
Primary	Length of stay post transfusion	Length of stay within the hospital after a blood transfusion. Applicable only to the 'acute transfusion' groups	1 month
Primary	Number of blood transfusions	Number of blood transfusions. Applicable only to the 'acute transfusion' groups	1 month
Primary	Hospital re-admission	Hospital re-admission. Applicable only to the 'acute transfusion' groups	1 month
Primary	Mortality rate	Mortality rate. Applicable only to the 'acute transfusion' groups	1 month.