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

Acute Leukemia Clinical Trial

Official title:

Development of a Method for Assessing the Functional Activity of Platelets for the Differential Diagnosis of Thrombocytopathies Using Flow Cytometry

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05654766
• Other study ID #: IBCE_PL1
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Acute Leukemia
• Blood Platelet Disorders
• Hemorrhagic Disorders
• Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopathy
• Thrombocytopenia

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