drugset / Trial / NCT03992001

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

NCT03992001 ↗

Phase 4 Completed 55 enrolled Università degli Studi di Ferrara
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2018-05-14
Primary completion
2019-07-31
Completion
2019-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Blood component A Unknown — —
Subject Blood component B Unknown — —