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

Not yet recruiting

• Conditions: Thrombocytopathy; Hemorrhagic Disorders; Immune Thrombocytopenia; Acute Leukemia
• Interventions: Diagnostic Test: Flow cytometry; Diagnostic Test: Platelet aggregation and plasma coagulation

• Registration Number: NCT05654766
• Lead Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

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

Study Timeline

• Status Verified: 2022-12
• Study First Submitted: 2022-12-08
• Study First Submitted QC: 2022-12-08
• Last Update Submitted: 2022-12-08
• Study First Posted: 2022-12-16
• Last Update Posted: 2022-12-16
• Study Start: 2023-01-02
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hemorrhagic syndrome and Acute Leukemia	Platelet aggregation and plasma coagulation	Group of pediatric participants with any manifestations of hemorrhagic syndrome and/or acute leukemia
Control group	Flow cytometry	Group of healthy adult and pediatric participants, whose blood platelets will be used to evaluate normal ranges of parameters in the flow cytometry PFT.
Hemorrhagic syndrome and Acute Leukemia	Flow cytometry	Group of pediatric participants with any manifestations of hemorrhagic syndrome and/or acute leukemia
Control group	Platelet aggregation and plasma coagulation	Group of healthy adult and pediatric participants, whose blood platelets will be used to evaluate normal ranges of parameters in the flow cytometry PFT.

Primary Outcome Measures

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