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

NCT03992001 | Completed Phase 4

• 1 other identifier: CrossoverFE2018
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Thalassemia Major

Keywords

Packed RBCs; leukodepletion; buffy-coat; transfusion

Outcome Measures

Primary Outcomes (1)

• Transfusion Power Index

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

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

Secondary Outcomes (5)

• Average pre-transfusion Hb concentration

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

• Unit Index

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

• Average Transfusion Interval

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

• Number of Transfusion Reactions

  Study periods (2 periods of 6 months each)

• Transfusion Reaction Rate

  Study periods (2 periods of 6 months each)

Study Arms (2)

Sequence A-B

EXPERIMENTAL

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; Biological: Blood component B

Sequence B-A

EXPERIMENTAL

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; Biological: Blood component B

Interventions

Blood component A BIOLOGICAL

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

Sequence A-B; Sequence B-A

Blood component B BIOLOGICAL

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

Sequence A-B; Sequence B-A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with beta(ß)-Thalassaemia transfusion-dependent (ß-Thalassemia Major or ß-Thalassemia Intermedia transfusion-dependent, regularly transfused since at least 5 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead

Study Sites (1)

Day Hospital Thalassaemia and Haemoglobinopathies (DHTE)

Ferrara, 44134, Italy

Location

MeSH Terms

Conditions

beta-Thalassemia

Condition Hierarchy (Ancestors)

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

Study Officials

• Maria Rita Gamberini, MD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Day Hospital Thalassaemia and Haemoglobinopathies (DHTE) - Azienda Ospedaliero-Universitaria S.Anna of Ferrara

Model Details: 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

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: June 19, 2019
• Study Start: May 14, 2018
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2019
• Last Updated: November 12, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication
• Access Criteria: Please contact the Central Contact Person

Locations

IT (1)