Clinical Use of Pathogen Reduced Red Blood Cell Suspension

Study Overview
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Brief Summary
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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
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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).

Official Title
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Clinical Application of Red Blood Cell Suspension, Obtained From the Pathogen Reduced Whole Blood in Children With Oncological and Hematological Diseases

Conditions
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Oncologic Disorders, Hematologic Diseases

Intervention / Treatment
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* Biological: Riboflavin+UV RBC
* Biological: irradiated RBC


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Riboflavin+UV RBC<br>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<br>* 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<br>|
| Active Comparator: irradiated RBC<br>35 patients who met all inclusion and exclusion criteria received transfusion with irradiated RBC suspension | Biological: irradiated RBC<br>* 35 patients who met all inclusion and exclusion criteria received transfusion with irradiated RBC suspension<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post-transfusion reactions | evaluate the presence and severity of post-transfusion reactions and complications. | 24 hours after transfusion | 
| augmentation of hemoglobin | Measure the patient's hemoglobin concentration (g/dL) the next day after the transfusion | 24 hours after transfusion | 
| augmentation of hematocrit | Measure the patient's hematocrit (%) the next day after the transfusion | 24 hours after transfusion | 
| immune responses | Perform direct antiglobuline test | 3-5 days after transfusion | 
| sensitization | perform indirect antiglobuline test | 2-3 weeks after transfusion | 
| intertransfusion interval | Evaluate the need for transfusions over the follow-up period (30 days) | 1 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patogen inactivation, Pathogen reduction, clinical use, riboflavin+UV, RBC transfusion, whole blood