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NCT Number: NCT03992001

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

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.

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Key information

Conditions

Thalassemia Major Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Thalassemia beta-Thalassemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Day Hospital Thalassaemia and Haemoglobinopathies (DHTE)

Ferrara, 44134, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood component A

Biological

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

Blood component B

Biological

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

Primary outcomes

  1. Transfusion Power Index

    Time frame: For each of the two blood components studied, at the end of 6-month period of study

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

Secondary outcomes

  1. Average pre-transfusion Hb concentration

    Time frame: For each of the two blood components studied, at the end of 6-month period of study

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

  2. Unit Index

    Time frame: For each of the two blood components studied, at the end of 6-month period of study

    (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)

  3. Average Transfusion Interval

    Time frame: For each of the two blood components studied, at the end of 6-month period of study

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

  4. Number of Transfusion Reactions

    Time frame: Study periods (2 periods of 6 months each)

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

  5. Transfusion Reaction Rate

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Università degli Studi di Ferrara

Other

Registry information

Official study 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)

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 19, 2019
Registry last updated
Nov 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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