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

Study Overview
=================
Brief 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.

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

Official Title
-----------------
Development of a Method for Assessing the Functional Activity of Platelets for the Differential Diagnosis of Thrombocytopathies Using Flow Cytometry

Conditions
-----------------
Immune Thrombocytopenia, Thrombocytopathy, Acute Leukemia, Hemorrhagic Disorders

Intervention / Treatment
-----------------
* Diagnostic Test: Flow cytometry
* Diagnostic Test: Platelet aggregation and plasma coagulation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control group<br>Group of healthy adult and pediatric participants, whose blood platelets will be used to evaluate normal ranges of parameters in the flow cytometry PFT. | Diagnostic Test: Flow cytometry<br>* Parameters such as FSC, SSC, median fluorescence of anti CD42b, PAC-1, CD41, CD63, CD62P, as well as Annexin V fluorescence will be assessed.<br>Diagnostic Test: Platelet aggregation and plasma coagulation<br>* Turbodimetric platelet aggregation test, impedance platelet aggregation test. Standard plasma coagulation test (fibrinogen level, prothrombin test, thrombin time, activated partial thromboplastin time (aPTT)).<br>|
| Hemorrhagic syndrome and Acute Leukemia<br>Group of pediatric participants with any manifestations of hemorrhagic syndrome and/or acute leukemia | Diagnostic Test: Flow cytometry<br>* Parameters such as FSC, SSC, median fluorescence of anti CD42b, PAC-1, CD41, CD63, CD62P, as well as Annexin V fluorescence will be assessed.<br>Diagnostic Test: Platelet aggregation and plasma coagulation<br>* Turbodimetric platelet aggregation test, impedance platelet aggregation test. Standard plasma coagulation test (fibrinogen level, prothrombin test, thrombin time, activated partial thromboplastin time (aPTT)).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Expression of CD42b by platelets | Assessment of platelet functional activity by the detection of CD42b | baseline | 
| Expression of CD41 by platelets | Assessment of platelet functional activity by the detection of CD41 | baseline | 
| Expression of PAC-1 by platelets | Assessment of platelet functional activity by the detection of PAC-1 | baseline | 
| Expression of CD63 by platelets | Assessment of platelet functional activity by the detection of CD63 | baseline | 
| Expression of CD62p by platelets | Assessment of platelet functional activity by the detection of CD62p | baseline | 
| Expression of Annexin V by platelets | Assessment of platelet functional activity by the detection of Annexin V | baseline | 
| Level of platelet aggregation | Assessment of platelet functional activity by turbidimetric aggregometry | baseline | 
| Impedance of platelet aggregates | Assessment of platelet functional activity by impedance aggregometry | baseline | 
| Fibrinogen level | Assessment of blood coagulation using Fibrinogen level test | baseline | 
| Prothrombin test | Assessment of blood coagulation using Prothrombin test | baseline | 
| Thrombin time | Assessment of blood coagulation using Thrombin time test | baseline | 
| aPTT | Assessment of blood coagulation using aPTT | baseline |