Impact of the Preparation Method of Red Cell Concentrates on Transfusion Indices in Thalassemic Patients

Università degli Studi di Ferrara

Status and phase: Completed; Phase 4

Conditions: Thalassemia Major

Treatments: Biological: Blood component A; Biological: Blood component B

Study type: Interventional

Funder types: Other

Identifiers

NCT03992001

CrossoverFE2018

Details and patient eligibility

About

This study compares the effects of Packed Red Blood Cells (PRBCs) prepared in two different ways on the transfusion indices in beta(ß)-Thalassemia transfusion-dependent patients. The two blood components types derive from the whole blood. In one case, the whole blood is leukoreduced with subsequent plasma removal. In the other case, plasma, buffy coat, and red blood cells (RBCs) are first separated and subsequently, the RBCs leukoreduced. Each type of blood components will be subsequently given to one-half of the patients for a 6-month period and to the other half for other 6-month at the randomization phase, for a total of 12 months of crossed-treatment per patient.

Full description

At Day Hospital Talassemia ed Emoglobinopatie of Ferrara, two different PRBCs are available. The two types of blood components are obtained from whole blood, pre-storage leukoreduced and suspended in saline-adenine-glucose-mannitol (SAGM). One method of preparation consists of the whole blood leukoreduction with subsequent plasma removal. The other method first separates plasma, buffy coat, and RBCs, and then the RBCs are leukoreduced. The two methods mainly differ in the final haemoglobin (Hb) content: the Hb level is lower (-13%, approximately) in the second method that also shows the advantage to produce platelets from the buffy coat. A PRBCs unit is not as strictly defined as a therapeutic medication dose (pill or vial): individual PRBCs units may substantially differ in their Hb content, much more than the average difference between the two types of preparations. The aim of this study is to document the extent of the average difference between the two types of preparations, and its impacts on the transfusion indices of ß-Thalassaemia transfusion-dependent patients. All patients will receive each blood component for a period of 6 months (crossover design), for a total of 12 months of transfusion treatment per patient.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient with beta(ß)-Thalassaemia transfusion-dependent (ß-Thalassemia Major or ß-Thalassemia Intermedia transfusion-dependent, regularly transfused since at least 5 years

Exclusion criteria

• Patient not exclusively transfused at Day Hospital Thalassaemia and Haemoglobinopathies of Ferrara
• Patient with haemolytic auto-antibodies
• Patient transfused with washed Packet RBCs units
• Severe splenomegaly (>18 cm on echography)
• Elevated blood consumption (>200 mL/kg of pure RBCs in the last year)
• Patient receiving haemoglobin inducers in the last 6 months
• Any significant clinical pulmonary, cardiovascular, endocrine, hepatic, gastrointestinal, renal, infectious, immunological including significant allo- or auto-immunisation disease, considered not adequately controlled prior to the study
• Patient treated with erythrocyte exchange
• Pregnant females

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

Sequence A-B

Experimental group

Description:

Patients in this arm will receive blood component A for 6 months and blood component B for the next 6 months

Treatment:

Biological: Blood component B

Biological: Blood component A

Sequence B-A

Experimental group

Description:

Patients in this arm will receive blood component B for 6 months and blood component A for the next 6 months

Treatment:

Biological: Blood component B

Biological: Blood component A