Recruitment

Recruitment Status
Completed
Estimated Enrollment
Same as current

Summary

Conditions
  • "Hematologic Diseases"
  • Oncologic Disorders
Type
Interventional
Phase
Phase 3
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Care Provider, Outcomes Assessor)Primary Purpose: Supportive Care

Participation Requirements

Age
Younger than 118 years
Gender
Both males and females

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 patie...

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).

Tracking Information

NCT #
NCT03426553
Collaborators
Not Provided
Investigators
Study Director: Pavel Trakhtman, PhD Federal Research Center for pediatric hematology, oncology and immunology