Clinical trial NCT03426553: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Oncologic Disorders
Hematologic Diseases
Keywords: Patogen inactivation
Pathogen reduction
clinical use
riboflavin+UV
RBC transfusion
whole blood
Lead sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Sponsor class: OTHER
First posted: 2018-02-08
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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

Primary outcomes:
measure: post-transfusion reactions
timeFrame: 24 hours after transfusion
measure: augmentation of hemoglobin
timeFrame: 24 hours after transfusion
measure: augmentation of hematocrit
timeFrame: 24 hours after transfusion
measure: immune responses
timeFrame: 3-5 days after transfusion
measure: sensitization
timeFrame: 2-3 weeks after transfusion
measure: intertransfusion interval
timeFrame: 1 months
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Federal Research Center for pediatric hematology, oncology and immunology
Study officials:
affiliation: Federal Research Center for pediatric hematology, oncology and immunology
name: Pavel Trakhtman, PhD
role: STUDY_DIRECTOR
References: