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Completed

NCT Number: NCT03426553

Clinical Use of Pathogen Reduced Red Blood Cell Suspension

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.

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Key information

Conditions

Oncologic Disorders Hematologic Diseases Hemic and Lymphatic Diseases

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Federal Research Center for pediatric hematology, oncology and immunology

Moscow, 117997, Russia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Riboflavin+UV RBC

Biological

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

Biological

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

Primary outcomes

  1. post-transfusion reactions

    Time frame: 24 hours after transfusion

    evaluate the presence and severity of post-transfusion reactions and complications.

  2. augmentation of hemoglobin

    Time frame: 24 hours after transfusion

    Measure the patient's hemoglobin concentration (g/dL) the next day after the transfusion

  3. augmentation of hematocrit

    Time frame: 24 hours after transfusion

    Measure the patient's hematocrit (%) the next day after the transfusion

  4. immune responses

    Time frame: 3-5 days after transfusion

    Perform direct antiglobuline test

  5. sensitization

    Time frame: 2-3 weeks after transfusion

    perform indirect antiglobuline test

  6. intertransfusion interval

    Time frame: 1 months

    Evaluate the need for transfusions over the follow-up period (30 days)

Sponsors and collaborators

Lead sponsor

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 8, 2018
Registry last updated
Dec 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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