Immune ThrombocytopeniaNCT05654766
Assesment of the Functional Activity of Platelets for the Differential Diagnosis of Thrombocytopathies
An observational study of Immune Thrombocytopenia and Thrombocytopathy, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus.
Trial summary
The purpose of this study is to develop a highly sensitive method for assessing the functional activity of platelets for use in the differential diagnosis of thrombocytopenia and platelet defects. Read more about this study
- Who is it for?
- Ages 1 year to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune Thrombocytopenia, Thrombocytopathy, Acute Leukemia
- What is being tested?
- Flow cytometry and Platelet aggregation and plasma coagulation
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2023to 31 Dec 2024
- Phase
- Observational
- 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 year to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Healthy pediatric volunteers aged 1 to 17. Pediatric volunteers aged 1 to 17 with any manifestation of hemorrhagic syndrome.
Who may be able to join
- Pediatric participants with hemorrhagic syndrome (hemorrhagic rash, bruising, bleeding, increased bleeding of the skin and mucous membranes, spontaneous hemorrhages in soft tissues and joints)
- Pediatric participants with acute leukemia
- Parameters of the plasma level of blood coagulation correspond to the age normal levels
Who cannot join
- Anticoagulation drug therapy
- Antiaggregation drug therapy
- Biologically active additives
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Development of a Method for Assessing the Functional Activity of Platelets for the Differential Diagnosis of Thrombocytopathies Using Flow Cytometry
The purpose of this study is to develop a highly sensitive method for assessing the functional activity of platelets for use in the differential diagnosis of thrombocytopenia and platelet defects.
Read the detailed description
The purpose of this study is to develop a highly sensitive method for assessing the functional activity of platelets using flow cytometry and turbidimetric and impedance aggregometry for use in the differential diagnosis of thrombocytopenia and platelet defects
- Being tested
- Flow cytometry, Platelet aggregation and plasma coagulation
- Medical subject headings
- Purpura, Thrombocytopenic, Idiopathic, Blood Platelet Disorders, Hemorrhagic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flow cytometryDiagnostic test
Parameters such as FSC, SSC, median fluorescence of anti CD42b, PAC-1, CD41, CD63, CD62P, as well as Annexin V fluorescence will be assessed.
Platelet aggregation and plasma coagulationDiagnostic test
Turbodimetric platelet aggregation test, impedance platelet aggregation test. Standard plasma coagulation test (fibrinogen level, prothrombin test, thrombin time, activated partial thromboplastin time (aPTT)).
| Study group | Role | What they receive |
|---|---|---|
| Control group | Group of healthy adult and pediatric participants, whose blood platelets will be used to evaluate normal ranges of parameters in the flow cytometry PFT. Receives: Diagnostic Test: Flow cytometry; Diagnostic Test: Platelet aggregation and plasma coagulation | |
| Hemorrhagic syndrome and Acute Leukemia | Group of pediatric participants with any manifestations of hemorrhagic syndrome and/or acute leukemia Receives: Diagnostic Test: Flow cytometry; Diagnostic Test: Platelet aggregation and plasma coagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of CD42b by platelets
Assessment of platelet functional activity by the detection of CD42b
Measured: baseline
Expression of CD41 by platelets
Assessment of platelet functional activity by the detection of CD41
Measured: baseline
Expression of PAC-1 by platelets
Assessment of platelet functional activity by the detection of PAC-1
Measured: baseline
Expression of CD63 by platelets
Assessment of platelet functional activity by the detection of CD63
Measured: baseline
Expression of CD62p by platelets
Assessment of platelet functional activity by the detection of CD62p
Measured: baseline
Expression of Annexin V by platelets
Assessment of platelet functional activity by the detection of Annexin V
Measured: baseline
Level of platelet aggregation
Assessment of platelet functional activity by turbidimetric aggregometry
Measured: baseline
Impedance of platelet aggregates
Assessment of platelet functional activity by impedance aggregometry
Measured: baseline
Fibrinogen level
Assessment of blood coagulation using Fibrinogen level test
Measured: baseline
Prothrombin test
Assessment of blood coagulation using Prothrombin test
Measured: baseline
Thrombin time
Assessment of blood coagulation using Thrombin time test
Measured: baseline
aPTT
Assessment of blood coagulation using aPTT
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start2 Jan 2023 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ThrombocytopeniaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
- Sponsor type
- Other government
- Collaborators
- Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
- Responsible party
- Sponsor
- Investigators
- rrchypp@gmail.com Shamova, Dr, Study director, the Institute of Biophysics and Cell Engineering of National Academy of Sciences of BelarusViacheslav Dmitriev, Dr, Study director, Belarussian Research Center for Pediatric Oncology, Hematology and Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654766
- Sponsor's protocol ID
- IBCE_PL1
- Status last verified
- Dec 2022
- First submitted
- 8 Dec 2022
- Last updated
- 16 Dec 2022
- 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 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Method for Assessing the Functional Activity of Platelets for the Differential Diagnosis of Thrombocytopathies Using Flow Cytometry
- ClinicalTrials.gov ID
- NCT05654766
- Acronym / sponsor ID
- IBCE_PL1
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of BelarusOther government
- Collaborators
- Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
- Study start
- 2 Jan 2023 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 16 Dec 2022 (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 purpose of this study is to develop a highly sensitive method for assessing the functional activity of platelets for use in the differential diagnosis of thrombocytopenia and platelet defects.
Detailed description
The purpose of this study is to develop a highly sensitive method for assessing the functional activity of platelets using flow cytometry and turbidimetric and impedance aggregometry for use in the differential diagnosis of thrombocytopenia and platelet defects
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | Diagnostic Test: Flow cytometry, Diagnostic Test: Platelet aggregation and plasma coagulationGroup of healthy adult and pediatric participants, whose blood platelets will be used to evaluate normal ranges of parameters in the flow cytometry PFT. |
| Hemorrhagic syndrome and Acute Leukemia | – | Diagnostic Test: Flow cytometry, Diagnostic Test: Platelet aggregation and plasma coagulationGroup of pediatric participants with any manifestations of hemorrhagic syndrome and/or acute leukemia |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Healthy pediatric volunteers aged 1 to 17. Pediatric volunteers aged 1 to 17 with any manifestation of hemorrhagic syndrome.
Key inclusion criteria (3 listed)
- Pediatric participants with hemorrhagic syndrome (hemorrhagic rash, bruising, bleeding, increased bleeding of the skin and mucous membranes, spontaneous hemorrhages in soft tissues and joints)
- Pediatric participants with acute leukemia
- Parameters of the plasma level of blood coagulation correspond to the age normal levels
Key exclusion criteria (3 listed)
- Anticoagulation drug therapy
- Antiaggregation drug therapy
- Biologically active additives
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 |
|---|---|---|
| Flow cytometryParameters such as FSC, SSC, median fluorescence of anti CD42b, PAC-1, CD41, CD63, CD62P, as well as Annexin V fluorescence will be assessed. | Diagnostic test | Control group, Hemorrhagic syndrome and Acute Leukemia |
| Platelet aggregation and plasma coagulationTurbodimetric platelet aggregation test, impedance platelet aggregation test. Standard plasma coagulation test (fibrinogen level, prothrombin test, thrombin time, activated partial thromboplastin time (aPTT)). | Diagnostic test | Control group, Hemorrhagic syndrome and Acute Leukemia |
Primary outcome
Expression of CD42b by platelets
Time frame: baseline
Assessment of platelet functional activity by the detection of CD42b
Expression of CD41 by platelets
Time frame: baseline
Assessment of platelet functional activity by the detection of CD41
Expression of PAC-1 by platelets
Time frame: baseline
Assessment of platelet functional activity by the detection of PAC-1
Expression of CD63 by platelets
Time frame: baseline
Assessment of platelet functional activity by the detection of CD63
Expression of CD62p by platelets
Time frame: baseline
Assessment of platelet functional activity by the detection of CD62p
Expression of Annexin V by platelets
Time frame: baseline
Assessment of platelet functional activity by the detection of Annexin V
Level of platelet aggregation
Time frame: baseline
Assessment of platelet functional activity by turbidimetric aggregometry
Impedance of platelet aggregates
Time frame: baseline
Assessment of platelet functional activity by impedance aggregometry
Fibrinogen level
Time frame: baseline
Assessment of blood coagulation using Fibrinogen level test
Prothrombin test
Time frame: baseline
Assessment of blood coagulation using Prothrombin test
Thrombin time
Time frame: baseline
Assessment of blood coagulation using Thrombin time test
aPTT
Time frame: baseline
Assessment of blood coagulation using aPTT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- Individual participant dataSharing planned: No
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RecruitingPhase 3
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RecruitingPhase 2
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RecruitingPhase 3
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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.
rrchypp@gmail.com Shamova, Dr study director
the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Viacheslav Dmitriev, Dr study director
Belarussian Research Center for Pediatric Oncology, Hematology and Immunology
Questions about this trial
What is this clinical trial studying?
An observational study of Immune Thrombocytopenia and Thrombocytopathy, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ekaterina Shamova, Dr (+375297520785, lubakova@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of CD42b by platelets (time frame: baseline). The study lists 12 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 16 Dec 2022.