Clinical Use of Pathogen Reduced Red Blood Cell Suspension

Sponsor

Federal Research Institute of Pediatric Hematology, Oncology and Immunology (Other)

Overall Status

Completed

CT.gov ID

NCT03426553

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

4.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Oncologic Disorders Hematologic Diseases	Biological: Riboflavin+UV RBC Biological: irradiated RBC	Phase 3

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

Actual Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jan 15, 2018

Actual Primary Completion Date :

Sep 17, 2018

Actual Study Completion Date :

Dec 17, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 18 Years

Sexes Eligible for Study:

All

Accepts 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