Oncologic DisordersPhase 3NCT03426553
Clinical Use of Pathogen Reduced Red Blood Cell Suspension
A Phase 3 study testing Riboflavin+UV RBC and irradiated RBC in people with Oncologic Disorders and Hematologic Diseases, run by Federal Research Institute of Pediatric Hematology, Oncology and Immunology at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Oncologic Disorders, Hematologic Diseases
- What is being tested?
- Riboflavin+UV RBC and irradiated RBC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteRussia
- Study dates
- 15 Jan 2018to 17 Dec 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients who need supportive transfusion therapy with RBC suspension
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site
Federal Research Center for pediatric hematology, oncology and immunology
Moscow, 117997
About this study
Official title: Clinical Application of Red Blood Cell Suspension, Obtained From the Pathogen Reduced Whole Blood in Children With Oncological and Hematological Diseases
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.
Read the 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
- Being tested
- Riboflavin+UV RBC, irradiated RBC
- Keywords
- Patogen inactivation, Pathogen reduction, clinical use, riboflavin+UV, RBC transfusion, whole blood
- Medical subject headings
- Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
irradiated RBCBiological
35 patients who met all inclusion and exclusion criteria received transfusion with irradiated RBC suspension
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Riboflavin+UV RBC |
| irradiated RBC | Active comparator | 35 patients who met all inclusion and exclusion criteria received transfusion with irradiated RBC suspension Receives: Biological: irradiated RBC |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-transfusion reactions
evaluate the presence and severity of post-transfusion reactions and complications.
Measured: 24 hours after transfusion
augmentation of hemoglobin
Measure the patient's hemoglobin concentration (g/dL) the next day after the transfusion
Measured: 24 hours after transfusion
augmentation of hematocrit
Measure the patient's hematocrit (%) the next day after the transfusion
Measured: 24 hours after transfusion
immune responses
Perform direct antiglobuline test
Measured: 3-5 days after transfusion
sensitization
perform indirect antiglobuline test
Measured: 2-3 weeks after transfusion
intertransfusion interval
Evaluate the need for transfusions over the follow-up period (30 days)
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2018
- Study start15 Jan 2018
- Primary completion17 Sep 2018
- Study completion17 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncologic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pavel Trakhtman, PhD, Study director, Federal Research Center for pediatric hematology, oncology and immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03426553
- Sponsor's protocol ID
- Rb+UV_WB_01_2017
- Status last verified
- Dec 2018
- First submitted
- 10 Oct 2017
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of Red Blood Cell Suspension, Obtained From the Pathogen Reduced Whole Blood in Children With Oncological and Hematological Diseases
- ClinicalTrials.gov ID
- NCT03426553
- Acronym / sponsor ID
- Rb+UV_WB_01_2017
- Conditions
- Oncologic Disorders, Hematologic Diseases
- Keywords
- Patogen inactivation, Pathogen reduction, clinical use, riboflavin+UV, RBC transfusion, whole blood
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and ImmunologyUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 17 Sep 2018 (actual)
- Study completion
- 17 Dec 2018 (actual)
- First posted
- 8 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Riboflavin+UV RBC | Experimental | Biological: Riboflavin+UV RBC35 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 | Active comparator | Biological: irradiated RBC35 patients who met all inclusion and exclusion criteria received transfusion with irradiated RBC suspension |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients who need supportive transfusion therapy with RBC suspension
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Riboflavin+UV RBC35 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 RBC35 patients who met all inclusion and exclusion criteria received transfusion with irradiated RBC suspension | Biological | irradiated RBC |
Primary outcome
post-transfusion reactions
Time frame: 24 hours after transfusion
evaluate the presence and severity of post-transfusion reactions and complications.
augmentation of hemoglobin
Time frame: 24 hours after transfusion
Measure the patient's hemoglobin concentration (g/dL) the next day after the transfusion
augmentation of hematocrit
Time frame: 24 hours after transfusion
Measure the patient's hematocrit (%) the next day after the transfusion
immune responses
Time frame: 3-5 days after transfusion
Perform direct antiglobuline test
sensitization
Time frame: 2-3 weeks after transfusion
perform indirect antiglobuline test
intertransfusion interval
Time frame: 1 months
Evaluate the need for transfusions over the follow-up period (30 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pavel Trakhtman, PhD study director
Federal Research Center for pediatric hematology, oncology and immunology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Riboflavin+UV RBC and irradiated RBC in people with Oncologic Disorders and Hematologic Diseases, run by Federal Research Institute of Pediatric Hematology, Oncology and Immunology at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-transfusion reactions (time frame: 24 hours after transfusion). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2018.