drugset / Trial / NCT03992001
Impact of the Preparation Method of Red Cell Concentrates on Transfusion Indices in Thalassemic Patients
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Blood component A | Unknown | — | — |
| Subject | Blood component B | Unknown | — | — |