Clinical Use of Pathogen Reduced Red Blood Cell Suspension

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Status and phase: Completed; Phase 3

Conditions: Hematologic Diseases; Oncologic Disorders

Treatments: Biological: Riboflavin+UV RBC; Biological: irradiated RBC

Study type: Interventional

Funder types: Other

Identifiers

NCT03426553

Rb+UV_WB_01_2017

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

Riboflavin+UV RBC

Experimental group

Description:

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

Treatment:

Biological: Riboflavin+UV RBC

irradiated RBC

Active Comparator group

Description:

35 patients who met all inclusion and exclusion criteria received transfusion with irradiated RBC suspension

Treatment:

Biological: irradiated RBC