Clinical Use of Pathogen Reduced Red Blood Cell Suspension

Phase 3

Completed

• Conditions: Hematologic Diseases; Oncologic Disorders

• Registration Number: NCT03426553
• Lead Sponsor: Federal Research Institute of Pediatric Hematology, Oncology and Immunology

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).

Study Timeline

• Study First Submitted: 2017-10-10
• Study Start: 2018-01-15
• Study First Submitted QC: 2018-02-07
• Study First Posted: 2018-02-08
• Primary Completion: 2018-09-17
• Status Verified: 2018-12
• Study Completion: 2018-12-17
• Last Update Submitted: 2018-12-21
• Last Update Posted: 2018-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
intertransfusion interval	1 months	Evaluate the need for transfusions over the follow-up period (30 days)
post-transfusion reactions	24 hours after transfusion	evaluate the presence and severity of post-transfusion reactions and complications.
sensitization	2-3 weeks after transfusion	perform indirect antiglobuline test
immune responses	3-5 days after transfusion	Perform direct antiglobuline test
augmentation of hematocrit	24 hours after transfusion	Measure the patient's hematocrit (%) the next day after the transfusion
augmentation of hemoglobin	24 hours after transfusion	Measure the patient's hemoglobin concentration (g/dL) the next day after the transfusion

Trial Locations

Locations (1)

Federal Research Center for pediatric hematology, oncology and immunology; 🇷🇺 Moscow, Russian Federation