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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05654766

Enrollment

200

Registered

2022-12-16

Start date

2023-01-02

Completion date

2024-12-31

Last updated

2022-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Leukemia, Hemorrhagic Disorders, Immune Thrombocytopenia, Thrombocytopathy

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

Interventions

DIAGNOSTIC_TESTFlow 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_TESTPlatelet 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)).

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 17 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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
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

Contacts

Primary ContactEkaterina Shamova, Dr

lubakova@gmail.com+375297520785

Backup ContactViacheslav Dmitriev, Dr

rrchypp@gmail.com+375296592670

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026