Innovative methodology: The development of a method to measure flow-based thrombin generation

Innovative methodology: The development of a method to measure flow-based thrombin generation - Diagnostic assay to measure secundairy hemostasis

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON37888

Enrollment

120

Registered

2012-03-28

Start date

2012-04-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

clotting hemostasis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Healthy men and women aged 18 to 65 years • Signed written consent to take part in the study

Exclusion criteria

Exclusion criteria: • Use of oral anticoagulants • Use of oral anti- platelet drugs • History of thrombosis and/or bleeding

Design outcomes

Primary

Measure	Time frame
The following parameters will be measured in the blood samples: • Thrombus generation and coagulation under flow in vitro. Thrombin generation is a dynamical process which includes platelets, coagulation factors and other blood cells. Thrombin generation can be triggered with different concentrations of tissue factor. • Control experiments need to be carried out per blood sample to check platelet count, quality, plasma quality and quality of whole blood using the standard procedures of our laboratory (flow cytometry, aggregometry, clotting). The main study parameters are thrombin generation and coagulation under flow conditions in vitro. Four different shear rates will be used to mimic arterial and venous blood flow and results will be compared. Furthermore four different tissue factor concentrations will be used. When no effect of shear rate is found on thrombin generation the study will be cancelled.	—

Measure

Time frame

The following parameters will be measured in the blood samples: • Thrombus generation and coagulation under flow in vitro. Thrombin generation is a dynamical process which includes platelets, coagulation factors and other blood cells. Thrombin generation can be triggered with different concentrations of tissue factor. • Control experiments need to be carried out per blood sample to check platelet count, quality, plasma quality and quality of whole blood using the standard procedures of our laboratory (flow cytometry, aggregometry, clotting). The main study parameters are thrombin generation and coagulation under flow conditions in vitro. Four different shear rates will be used to mimic arterial and venous blood flow and results will be compared. Furthermore four different tissue factor concentrations will be used. When no effect of shear rate is found on thrombin generation the study will be cancelled.

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Secondary

Measure	Time frame
NA.	—

Countries

Netherlands

Outcome results