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

Sponsor

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05654766

Collaborator

Belarusian Research Center for Pediatric Oncology, Hematology and Immunology (Other)

200

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Immune Thrombocytopenia Thrombocytopathy Acute Leukemia Hemorrhagic Disorders	Diagnostic Test: Flow cytometry Diagnostic Test: Platelet aggregation and plasma coagulation

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

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jan 2, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.	Diagnostic Test: 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. 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)).
Hemorrhagic syndrome and Acute Leukemia Group of pediatric participants with any manifestations of hemorrhagic syndrome and/or acute leukemia	Diagnostic Test: 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. 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)).

Arm

Intervention/Treatment

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.

Diagnostic Test: 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.

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)).

Hemorrhagic syndrome and Acute Leukemia

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

Diagnostic Test: 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.

Diagnostic Test: Platelet aggregation and plasma coagulation

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Belarusian Research Center for Pediatric Oncology, Hematology and Immunology

Investigators

Study Director: rrchypp@gmail.com Shamova, Dr, the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Study Director: Viacheslav Dmitriev, Dr, Belarussian Research Center for Pediatric Oncology, Hematology and Immunology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT05654766

Other Study ID Numbers:

IBCE_PL1

First Posted:

Dec 16, 2022

Last Update Posted:

Dec 16, 2022

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Thrombocytopenia

Purpura, Thrombocytopenic, Idiopathic

Hemorrhagic Disorders

Blood Platelet Disorders

Study Results

No Results Posted as of Dec 16, 2022