Clinical trial NCT03992001: Impact of the Preparation Method of Red Cell Concentrates on Transfusion Indices in Thalassemic Patients
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Thalassemia Major
Keywords: Packed RBCs
leukodepletion
buffy-coat
transfusion
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
First posted: 2019-06-19
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Transfusion Power Index
timeFrame: For each of the two blood components studied, at the end of 6-month period of study
Secondary outcomes:
measure: Average pre-transfusion Hb concentration
timeFrame: For each of the two blood components studied, at the end of 6-month period of study
measure: Unit Index
timeFrame: For each of the two blood components studied, at the end of 6-month period of study
measure: Average Transfusion Interval
timeFrame: For each of the two blood components studied, at the end of 6-month period of study
measure: Number of Transfusion Reactions
timeFrame: Study periods (2 periods of 6 months each)
measure: Transfusion Reaction Rate
timeFrame: Study periods (2 periods of 6 months each)
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Day Hospital Thalassaemia and Haemoglobinopathies (DHTE)
Study officials:
affiliation: D.H. Thalassaemia-Haemoglobinopathies (DHTE) - A.O.U. S. Anna of Ferrara
name: Maria Rita Gamberini, MD
role: STUDY_CHAIR
References: