Status:
COMPLETED
Clinical Use of Pathogen Reduced Red Blood Cell Suspension
Lead Sponsor:
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Conditions:
Oncologic Disorders
Hematologic Diseases
Eligibility:
All Genders
1-18 years
Phase:
PHASE3
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 gr...
Eligibility Criteria
Inclusion
- Patients who need supportive transfusion therapy with RBC suspension
Exclusion
- 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
Key Trial Info
Start Date :
January 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03426553
Start Date
January 15 2018
End Date
December 17 2018
Last Update
December 24 2018
Active Locations (1)
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1
Federal Research Center for pediatric hematology, oncology and immunology
Moscow, Russia, 117997