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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05654766
Other study ID # IBCE_PL1
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 2, 2023
Est. completion date December 31, 2024

Study information

Verified date December 2022
Source Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Contact Ekaterina Shamova, Dr
Phone +375297520785
Email lubakova@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date December 31, 2024
Est. primary completion date December 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year to 17 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.
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)).

Locations

Country Name City State
n/a

Sponsors (2)

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

Outcome

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