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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemorrhagic Disorders; Immune Thrombocytopenia; Acute Leukemia; Thrombocytopathy
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Ekaterina Shamova, Dr; Phone Number: +375297520785; Email: lubakova@gmail.com
• Study Contact Backup: Name: Viacheslav Dmitriev, Dr; Phone Number: +375296592670; Email: rrchypp@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy pediatric volunteers aged 1 to 17. Pediatric volunteers aged 1 to 17 with any manifestation of hemorrhagic syndrome.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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)).

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

Collaborators and Investigators

• Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
• Collaborators: 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 record dates

Study Major Dates

• Study Start (Anticipated): January 2, 2023
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: December 8, 2022
• First Submitted That Met QC Criteria: December 8, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Actual): December 16, 2022
• Last Update Submitted That Met QC Criteria: December 8, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Hematologic Diseases; Hemorrhage; Blood Coagulation Disorders; Skin Manifestations; Thrombotic Microangiopathies; Purpura, Thrombocytopenic; Purpura; Purpura, Thrombocytopenic, Idiopathic; Hemorrhagic Disorders; Thrombocytopenia; Blood Platelet Disorders
• Other Study ID Numbers: IBCE_PL1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No