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

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

Prospective Crossover Study on Beta(ß)-Thalassaemia Transfusion-dependent to Evaluate the Impact on Transfusion Regimen of Two Pre-storage Leukoreduced PRBCs(In-line Filtration + B-C Separation; Whole Blood Filtration + B-C Conservation)

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.

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.

Patients will be divided into two groups of approximately equal number. The first group will receive the blood component A for a period of 6 months and then the blood component B for the next 6 months. The second group will receive the blood components in inverted order

The patients will not be informed on the blood components sequence that they will receive. However, the units exterior appearance of the two types of preparations is different. For this reason, patients and care providers will most probably notice it.

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

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

PRBCs obtained from whole blood after separation of plasma, buffy coat, and RBCs and successive leukoreduction of RBCs

(Average pre-transfusion Hb concentration)/(Unit Index) [for the definition of Unit Index, see the secondary outcomes]

Mean pre-transfusion Hb levels, calculated starting from the second transfusion of the period to the first transfusion of the following period

(Total number of PRBCs (A or B) transfused in the period)/(Number of days between the first transfusion of the period and the first transfusion of the following period)

(Number of days between the first transfusion of the period and the first transfusion of the following period)/(Number of transfusions in the period)

Number of transfusion reactions to the two blood components that may occur in the study periods (2 periods of 6 months each)

(Number of transfusion reactions to the two blood components occurring in the study periods)/(Total number of PRBCs (A or B) transfused in the period)

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

There is a plan to make IPD (deidentified) available to other researchers and support already published results