Clinical Use of Pathogen Reduced Red Blood Cell Suspension

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

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.

Study Overview

• Status: Completed
• Conditions: Hematologic Diseases; Oncologic Disorders
• Intervention / Treatment: Biological: Riboflavin+UV RBC; Biological: irradiated RBC

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 117997
    • Federal Research Center for pediatric hematology, oncology and immunology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Biological: 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
Active Comparator: irradiated 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 irradiated RBC suspension

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
• Investigators: Study Director: Pavel Trakhtman, PhD, Federal Research Center for pediatric hematology, oncology and immunology

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Actual): September 17, 2018
• Study Completion (Actual): December 17, 2018

Study Registration Dates

• First Submitted: October 10, 2017
• First Submitted That Met QC Criteria: February 7, 2018
• First Posted (Actual): February 8, 2018

Study Record Updates

• Last Update Posted (Actual): December 24, 2018
• Last Update Submitted That Met QC Criteria: December 21, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: whole blood; RBC transfusion; Pathogen reduction; Patogen inactivation; clinical use; riboflavin+UV
• Additional Relevant MeSH Terms: Hematologic Diseases; Physiological Effects of Drugs; Photosensitizing Agents; Dermatologic Agents; Micronutrients; Vitamins; Vitamin B Complex; Riboflavin
• Other Study ID Numbers: Rb+UV_WB_01_2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No