NCT03426553

Clinical Use of Pathogen Reduced Red Blood Cell Suspension

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology · Academic / Other
• Sex: All
• Age: 1 Month – 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Oncologic Disorders
• Hematologic Diseases

Interventions

Type	Name	Description
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
BIOLOGICAL	irradiated RBC	35 patients who met all inclusion and exclusion criteria received transfusion with irradiated RBC suspension

Timeline

• Start date: 2018-01-15
• Primary completion: 2018-09-17
• Completion: 2018-12-17
• First posted: 2018-02-08
• Last updated: 2018-12-24

Locations

1 site across 1 country: Russia