The aim of the study is to evaluate the effectiveness and safety of the application of pathogen inactivated RBC suspension in children with oncological and hematological diseases.
Assumed scope of study: The study will include 70 patients: 35 patients to the test group, who will get transfusions with pathogen-inactivated red blood cell suspension; 35 patients to the control group, who will get transfusions with irradiated red blood cell suspension. Methods: * Selection of patients suitable to participate in the study. * A few days before the assumed transfusion date, select/prepare a red blood cell suspension corresponding to ABO and Rh systems, with no more than 14 days of storage. Conduct direct antiglobuline test (DAT), indirect antiglobuline test (IAT) and test for individual compatibility with the patient's serum. * Before performing transfusion (on the day of transfusion), determine the initial indices of the patient (Hb, Hct, Haptoglobin). Determine the red blood cell suspension indices (Hb, Hct, extracellular potassium, free hemoglobin, hemolysis percentage). * Perform transfusion. Evaluate the presence and severity of post-transfusion reactions and complications. * Measure the patient's Hb, Hct, potassium and haptoglobin levels the next day after the transfusion. * Perform DAT 3 to 5 five days after the transfusion. * Perform IAT 2 to 3 weeks after the transfusion. * Evaluate the need for transfusions over the follow-up period (30 days).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
50
35 patients who met all inclusion and exclusion criteria received transfusion with RBC suspension from whole blood, treated with riboflavin and ultraviolet pathogen reduction technology
35 patients who met all inclusion and exclusion criteria received transfusion with irradiated RBC suspension
Federal Research Center for pediatric hematology, oncology and immunology
Moscow, Russia
post-transfusion reactions
evaluate the presence and severity of post-transfusion reactions and complications.
Time frame: 24 hours after transfusion
augmentation of hemoglobin
Measure the patient's hemoglobin concentration (g/dL) the next day after the transfusion
Time frame: 24 hours after transfusion
augmentation of hematocrit
Measure the patient's hematocrit (%) the next day after the transfusion
Time frame: 24 hours after transfusion
immune responses
Perform direct antiglobuline test
Time frame: 3-5 days after transfusion
sensitization
perform indirect antiglobuline test
Time frame: 2-3 weeks after transfusion
intertransfusion interval
Evaluate the need for transfusions over the follow-up period (30 days)
Time frame: 1 months
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