A Phase 3 interventional study of Riboflavin+UV RBC and irradiated RBC in Oncologic Disorders and Hematologic Diseases, sponsored by Federal Research Institute of Pediatric Hematology, Oncology and Immunology. Completed at 1 site in Russian Federation. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2018-12-24.
Sponsored by Federal Research Institute of Pediatric Hematology, Oncology and Immunology · Phase 3, Interventional, and Supportive care
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:
Patients who need supportive transfusion therapy with RBC suspension
Exclusion Criteria:
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
Biological: Riboflavin+UV RBC
35 patients who met all inclusion and exclusion criteria received transfusion with irradiated RBC suspension
Biological: irradiated 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
35 patients who met all inclusion and exclusion criteria received transfusion with irradiated RBC suspension
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Federal Research Institute of Pediatric Hematology, Oncology and Immunology