Hematologic Diseases, Oncologic Disorders
Conditions
Keywords
Patogen inactivation, Pathogen reduction, clinical use, riboflavin+UV, RBC transfusion, whole blood
Brief summary
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.
Detailed description
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).
Interventions
BIOLOGICALRiboflavin+UV RBC
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
BIOLOGICALirradiated RBC
35 patients who met all inclusion and exclusion criteria received transfusion with irradiated RBC suspension
Sponsors
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
Patients who need supportive transfusion therapy with RBC suspension
Exclusion criteria
* Active bleeding * Sepsis/severe infection (any infectious disease requiring pressor agents, infusion and respiratory support) * Positive DAT and / or IAT before transfusion * Double populations for ABO and RH blood group antigens * Severe hepatomegaly/splenomegaly * Patients receiving chemotherapy (at the time of need for transfusion) * Patients receiving antithymocyte immunoglobulin and also within 7 days after its completion * Patients requiring transfusion of only irradiated blood components
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| post-transfusion reactions | 24 hours after transfusion | evaluate the presence and severity of post-transfusion reactions and complications. |
| augmentation of hemoglobin | 24 hours after transfusion | Measure the patient's hemoglobin concentration (g/dL) the next day after the transfusion |
| augmentation of hematocrit | 24 hours after transfusion | Measure the patient's hematocrit (%) the next day after the transfusion |
| immune responses | 3-5 days after transfusion | Perform direct antiglobuline test |
| sensitization | 2-3 weeks after transfusion | perform indirect antiglobuline test |
| intertransfusion interval | 1 months | Evaluate the need for transfusions over the follow-up period (30 days) |
Countries
Russia
Outcome results
None listed