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

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ClinicalTrials.gov Identifier: NCT03992001
Recruitment Status : Enrolling by invitation
First Posted : June 19, 2019
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Maria Rita Gamberini, Università degli Studi di Ferrara

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.

Condition or disease Intervention/treatment Phase
Thalassemia Major Biological: Blood component A Biological: Blood component B Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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
Masking: None (Open Label)
Masking Description: 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.
Primary Purpose: Treatment
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)
Actual Study Start Date : May 14, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019


Arm Intervention/treatment
Experimental: Sequence A-B
Patients in this arm will receive blood component A for 6 months and blood component B for the next 6 months
Biological: Blood component A
PRBCs obtained from whole blood after separation of plasma, buffy coat, and RBCs and successive leukoreduction of RBCs

Biological: Blood component B
PRBCs obtained by leukoreduction of whole blood, and successive separation of plasma and RBCs

Experimental: Sequence B-A
Patients in this arm will receive blood component B for 6 months and blood component A for the next 6 months
Biological: Blood component A
PRBCs obtained from whole blood after separation of plasma, buffy coat, and RBCs and successive leukoreduction of RBCs

Biological: Blood component B
PRBCs obtained by leukoreduction of whole blood, and successive separation of plasma and RBCs




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03992001


Locations
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Italy
Day Hospital Thalassaemia and Haemoglobinopathies (DHTE)
Ferrara, Italy, 44134
Sponsors and Collaborators
Università degli Studi di Ferrara
Investigators
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Study Chair: Maria Rita Gamberini, MD D.H. Thalassaemia-Haemoglobinopathies (DHTE) - A.O.U. S. Anna of Ferrara

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Responsible Party: Maria Rita Gamberini, Head, Day Hospital Thalassaemia and Haemoglobinopathies (DHTE) - Azienda Ospedaliero-Universitaria S.Anna of Ferrara, Università degli Studi di Ferrara
ClinicalTrials.gov Identifier: NCT03992001    
Other Study ID Numbers: CrossoverFE2018
First Posted: June 19, 2019    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: There is a plan to make IPD (deidentified) available to other researchers and support already published results
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Beginning 3 months and ending 3 years following article publication
Access Criteria: Please contact the Central Contact Person

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Maria Rita Gamberini, Università degli Studi di Ferrara:
Packed RBCs
leukodepletion
buffy-coat
transfusion
Additional relevant MeSH terms:
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Thalassemia
beta-Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn