NCT03426553

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

January 15, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 8, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 17, 2018

Completed
Last Updated

December 24, 2018

Status Verified

December 1, 2018

Enrollment Period

8 months

First QC Date

October 10, 2017

Last Update Submit

December 21, 2018

Conditions

Oncologic DisordersHematologic Diseases

Keywords

Patogen inactivationPathogen reductionclinical useriboflavin+UVRBC transfusionwhole blood

Outcome Measures

Primary Outcomes (6)

  • post-transfusion reactions

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

    24 hours after transfusion

  • augmentation of hemoglobin

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

    24 hours after transfusion

  • augmentation of hematocrit

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

    24 hours after transfusion

  • immune responses

    Perform direct antiglobuline test

    3-5 days after transfusion

  • sensitization

    perform indirect antiglobuline test

    2-3 weeks after transfusion

  • intertransfusion interval

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

    1 months

Study Arms (2)

Riboflavin+UV RBC

EXPERIMENTAL

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: Riboflavin+UV RBC

irradiated RBC

ACTIVE COMPARATOR

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

Biological: irradiated RBC

Interventions

Riboflavin+UV RBCBIOLOGICAL

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

Riboflavin+UV RBC
irradiated RBCBIOLOGICAL

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

irradiated RBC

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients who need supportive transfusion therapy with RBC suspension

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal Research Center for pediatric hematology, oncology and immunology

Moscow, 117997, Russia

Location

MeSH Terms

Conditions

Hematologic Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Officials

  • Pavel Trakhtman, PhD

    Federal Research Center for pediatric hematology, oncology and immunology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2017

First Posted

February 8, 2018

Study Start

January 15, 2018

Primary Completion

September 17, 2018

Study Completion

December 17, 2018

Last Updated

December 24, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)