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

NCT ID: NCT03992001

Last Updated: 2021-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-14

Study Completion Date

2019-07-31

Brief Summary

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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

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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.

Conditions

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Thalassemia Major

Keywords

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Packed RBCs leukodepletion buffy-coat transfusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

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Sequence A-B

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

Group Type EXPERIMENTAL

Blood component A

Intervention Type BIOLOGICAL

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

Blood component B

Intervention Type BIOLOGICAL

PRBCs obtained by leukoreduction of whole blood, and successive separation of plasma and RBCs

Sequence B-A

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

Group Type EXPERIMENTAL

Blood component A

Intervention Type BIOLOGICAL

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

Blood component B

Intervention Type BIOLOGICAL

PRBCs obtained by leukoreduction of whole blood, and successive separation of plasma and RBCs

Interventions

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Blood component A

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

Intervention Type BIOLOGICAL

Blood component B

PRBCs obtained by leukoreduction of whole blood, and successive separation of plasma and RBCs

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi di Ferrara

OTHER

Sponsor Role lead

Responsible Party

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Maria Rita Gamberini

Head, Day Hospital Thalassaemia and Haemoglobinopathies (DHTE) - Azienda Ospedaliero-Universitaria S.Anna of Ferrara

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Rita Gamberini, MD

Role: STUDY_CHAIR

D.H. Thalassaemia-Haemoglobinopathies (DHTE) - A.O.U. S. Anna of Ferrara

Locations

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Day Hospital Thalassaemia and Haemoglobinopathies (DHTE)

Ferrara, , Italy

Site Status

Countries

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Italy

Other Identifiers

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CrossoverFE2018

Identifier Type: -

Identifier Source: org_study_id