Clinical Use of Pathogen Reduced Red Blood Cell Suspension
NCT ID: NCT03426553
Last Updated: 2018-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
50 participants
INTERVENTIONAL
2018-01-15
2018-12-17
Brief Summary
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Detailed Description
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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).
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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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
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
irradiated RBC
35 patients who met all inclusion and exclusion criteria received transfusion with irradiated RBC suspension
irradiated RBC
35 patients who met all inclusion and exclusion criteria received transfusion with irradiated RBC suspension
Interventions
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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
irradiated RBC
35 patients who met all inclusion and exclusion criteria received transfusion with irradiated RBC suspension
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
1 Month
18 Years
ALL
No
Sponsors
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Federal Research Institute of Pediatric Hematology, Oncology and Immunology
OTHER
Responsible Party
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Principal Investigators
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Pavel Trakhtman, PhD
Role: STUDY_DIRECTOR
Federal Research Center for pediatric hematology, oncology and immunology
Locations
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Federal Research Center for pediatric hematology, oncology and immunology
Moscow, , Russia
Countries
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Other Identifiers
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Rb+UV_WB_01_2017
Identifier Type: -
Identifier Source: org_study_id