Clinical Application of Red Blood Cell Suspension, Obtained From the Pathogen Reduced Whole Blood in Children With Oncological and Hematological Diseases
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- augmentation of hemoglobin
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Month to 18 Years (Child, Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Riboflavin+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
Intervention: Riboflavin+UV RBC (Biological)
irradiated RBC
35 patients who met all inclusion and exclusion criteria received transfusion with irradiated RBC suspension
Intervention: irradiated RBC (Biological)
Outcomes
Primary Outcomes
augmentation of hemoglobin
Time Frame: 24 hours after transfusion
Measure the patient's hemoglobin concentration (g/dL) the next day after the transfusion
intertransfusion interval
Time Frame: 1 months
Evaluate the need for transfusions over the follow-up period (30 days)
post-transfusion reactions
Time Frame: 24 hours after transfusion
evaluate the presence and severity of post-transfusion reactions and complications.
sensitization
Time Frame: 2-3 weeks after transfusion
perform indirect antiglobuline test
augmentation of hematocrit
Time Frame: 24 hours after transfusion
Measure the patient's hematocrit (%) the next day after the transfusion
immune responses
Time Frame: 3-5 days after transfusion
Perform direct antiglobuline test
Secondary Outcomes
No secondary outcomes reported