Clinical Use of Pathogen Reduced Red Blood Cell Suspension

Hematologic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03426553
• Other study ID #: Rb+UV_WB_01_2017
• Status: Completed
• Phase: Phase 3
• Start date: January 15, 2018
• Est. completion date: December 17, 2018

Study information

• Verified date: December 2018
• Source: Federal Research Institute of Pediatric Hematology, Oncology and Immunology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 17, 2018
• Est. primary completion date: September 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Diseases
• Oncologic Disorders

Intervention

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
• irradiated RBC
35 patients who met all inclusion and exclusion criteria received transfusion with irradiated RBC suspension

Locations

Country	Name	City	State
Russian Federation	Federal Research Center for pediatric hematology, oncology and immunology	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Country where clinical trial is conducted

Russian Federation, 

Outcome

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