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

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus200 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

200

Conditions

Immune Thrombocytopenia Thrombocytopathy Acute Leukemia Hemorrhagic Disorders

Interventions

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)).

Eligibility

Sex: ALLMin age: 1 YearMax age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Expression of CD42b by platelets

Assessment of platelet functional activity by the detection of CD42b

Time frame: baseline

Expression of CD41 by platelets

Assessment of platelet functional activity by the detection of CD41

Time frame: baseline

Expression of PAC-1 by platelets

Assessment of platelet functional activity by the detection of PAC-1

Time frame: baseline

Expression of CD63 by platelets

Assessment of platelet functional activity by the detection of CD63

Time frame: baseline

Expression of CD62p by platelets

Assessment of platelet functional activity by the detection of CD62p

Time frame: baseline

Expression of Annexin V by platelets

Assessment of platelet functional activity by the detection of Annexin V

Time frame: baseline

Level of platelet aggregation

Assessment of platelet functional activity by turbidimetric aggregometry

Time frame: baseline

Impedance of platelet aggregates

Assessment of platelet functional activity by impedance aggregometry

Time frame: baseline

Fibrinogen level

Assessment of blood coagulation using Fibrinogen level test

Central Contacts

Ekaterina Shamova, Dr

CONTACT

+375297520785 lubakova@gmail.com

Viacheslav Dmitriev, Dr

CONTACT

+375296592670 rrchypp@gmail.com

Data from ClinicalTrials.gov

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