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Assesment of the Functional Activity of Platelets for the Differential Diagnosis of Thrombocytopathies

NCT ID: NCT05654766

Last Updated: 2022-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-02

Study Completion Date

2024-12-31

Brief Summary

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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

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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

Conditions

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Immune Thrombocytopenia Thrombocytopathy Acute Leukemia Hemorrhagic Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Flow cytometry

Intervention Type DIAGNOSTIC_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 coagulation

Intervention Type DIAGNOSTIC_TEST

Turbodimetric platelet aggregation test, impedance platelet aggregation test. Standard plasma coagulation test (fibrinogen level, prothrombin test, thrombin time, activated partial thromboplastin time (aPTT)).

Hemorrhagic syndrome and Acute Leukemia

Group of pediatric participants with any manifestations of hemorrhagic syndrome and/or acute leukemia

Flow cytometry

Intervention Type DIAGNOSTIC_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 coagulation

Intervention Type DIAGNOSTIC_TEST

Turbodimetric platelet aggregation test, impedance platelet aggregation test. Standard plasma coagulation test (fibrinogen level, prothrombin test, thrombin time, activated partial thromboplastin time (aPTT)).

Interventions

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Flow cytometry

Parameters such as FSC, SSC, median fluorescence of anti CD42b, PAC-1, CD41, CD63, CD62P, as well as Annexin V fluorescence will be assessed.

Intervention Type DIAGNOSTIC_TEST

Platelet aggregation and plasma coagulation

Turbodimetric platelet aggregation test, impedance platelet aggregation test. Standard plasma coagulation test (fibrinogen level, prothrombin test, thrombin time, activated partial thromboplastin time (aPTT)).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Anticoagulation drug therapy
* Antiaggregation drug therapy
* Biologically active additives
Minimum Eligible Age

1 Year

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

OTHER

Sponsor Role collaborator

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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[email protected] Shamova, Dr

Role: STUDY_DIRECTOR

the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Viacheslav Dmitriev, Dr

Role: STUDY_DIRECTOR

Belarussian Research Center for Pediatric Oncology, Hematology and Immunology

Central Contacts

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Ekaterina Shamova, Dr

Role: CONTACT

Phone: +375297520785

Email: [email protected]

Viacheslav Dmitriev, Dr

Role: CONTACT

Phone: +375296592670

Email: [email protected]

Other Identifiers

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IBCE_PL1

Identifier Type: -

Identifier Source: org_study_id