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Clinical Use of Pathogen Reduced Red Blood Cell Suspension

Primary Purpose

Oncologic Disorders, Hematologic Diseases

Status
Completed
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Riboflavin+UV RBC
irradiated RBC
Sponsored by
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Oncologic Disorders focused on measuring Patogen inactivation, Pathogen reduction, clinical use, riboflavin+UV, RBC transfusion, whole blood

Eligibility Criteria

1 Month - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Federal Research Center for pediatric hematology, oncology and immunology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Riboflavin+UV RBC

irradiated RBC

Arm 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

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

Outcomes

Primary Outcome Measures

post-transfusion reactions
evaluate the presence and severity of post-transfusion reactions and complications.
augmentation of hemoglobin
Measure the patient's hemoglobin concentration (g/dL) the next day after the transfusion
augmentation of hematocrit
Measure the patient's hematocrit (%) the next day after the transfusion
immune responses
Perform direct antiglobuline test
sensitization
perform indirect antiglobuline test
intertransfusion interval
Evaluate the need for transfusions over the follow-up period (30 days)

Secondary Outcome Measures

Full Information

First Posted
October 10, 2017
Last Updated
December 21, 2018
Sponsor
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
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1. Study Identification

Unique Protocol Identification Number
NCT03426553
Brief Title
Clinical Use of Pathogen Reduced Red Blood Cell Suspension
Official Title
Clinical Application of Red Blood Cell Suspension, Obtained From the Pathogen Reduced Whole Blood in Children With Oncological and Hematological Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
September 17, 2018 (Actual)
Study Completion Date
December 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federal Research Institute of Pediatric Hematology, Oncology and Immunology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oncologic Disorders, Hematologic Diseases
Keywords
Patogen inactivation, Pathogen reduction, clinical use, riboflavin+UV, RBC transfusion, whole blood

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Riboflavin+UV RBC
Arm Type
Experimental
Arm 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
Arm Title
irradiated RBC
Arm Type
Active Comparator
Arm Description
35 patients who met all inclusion and exclusion criteria received transfusion with irradiated RBC suspension
Intervention Type
Biological
Intervention Name(s)
Riboflavin+UV RBC
Intervention 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
Intervention Type
Biological
Intervention Name(s)
irradiated RBC
Intervention Description
35 patients who met all inclusion and exclusion criteria received transfusion with irradiated RBC suspension
Primary Outcome Measure Information:
Title
post-transfusion reactions
Description
evaluate the presence and severity of post-transfusion reactions and complications.
Time Frame
24 hours after transfusion
Title
augmentation of hemoglobin
Description
Measure the patient's hemoglobin concentration (g/dL) the next day after the transfusion
Time Frame
24 hours after transfusion
Title
augmentation of hematocrit
Description
Measure the patient's hematocrit (%) the next day after the transfusion
Time Frame
24 hours after transfusion
Title
immune responses
Description
Perform direct antiglobuline test
Time Frame
3-5 days after transfusion
Title
sensitization
Description
perform indirect antiglobuline test
Time Frame
2-3 weeks after transfusion
Title
intertransfusion interval
Description
Evaluate the need for transfusions over the follow-up period (30 days)
Time Frame
1 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pavel Trakhtman, PhD
Organizational Affiliation
Federal Research Center for pediatric hematology, oncology and immunology
Official's Role
Study Director
Facility Information:
Facility Name
Federal Research Center for pediatric hematology, oncology and immunology
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Use of Pathogen Reduced Red Blood Cell Suspension

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