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

NCT05654766 | Unknown

• 1 other identifier: IBCE_PL1
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Immune Thrombocytopenia; Thrombocytopathy; Acute Leukemia; Hemorrhagic Disorders

Outcome Measures

Primary Outcomes (12)

• 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

Study Arms (2)

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; Diagnostic Test: Platelet aggregation and plasma coagulation

Hemorrhagic syndrome and Acute Leukemia

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

Diagnostic Test: Flow cytometry; Diagnostic Test: Platelet aggregation and plasma coagulation

Interventions

Flow cytometry DIAGNOSTIC_TEST

Parameters such as FSC, SSC, median fluorescence of anti CD42b, PAC-1, CD41, CD63, CD62P, as well as Annexin V fluorescence will be assessed.

Control group; Hemorrhagic syndrome and Acute Leukemia

Platelet aggregation and plasma coagulation DIAGNOSTIC_TEST

Turbodimetric platelet aggregation test, impedance platelet aggregation test. Standard plasma coagulation test (fibrinogen level, prothrombin test, thrombin time, activated partial thromboplastin time (aPTT)).

Control group; Hemorrhagic syndrome and Acute Leukemia

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Anticoagulation drug therapy
• Antiaggregation drug therapy
• Biologically active additives

Sponsors & Collaborators

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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic; Blood Platelet Disorders; Hemorrhagic Disorders

Interventions

Flow Cytometry; Platelet Aggregation

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Cytopenia; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Hemorheology; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Platelet Activation; Hemostasis

Study Officials

• 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 DIRECTOR

Central Study Contacts

Ekaterina Shamova, Dr

CONTACT

+375297520785; lubakova@gmail.com

Viacheslav Dmitriev, Dr

CONTACT

+375296592670; rrchypp@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 16, 2022
• Study Start: January 2, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2024
• Last Updated: December 16, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share