Platelet behaviour in Hereditary Thrombocytopathies. An observational study on the platelet characteristics of a known bleeding disorder with two novel instruments.

Platelet behaviour in Hereditary Thrombocytopathies. An observational study on the platelet characteristics of a known bleeding disorder with two novel instruments. - Platelet behaviour in Hereditary Thrombocytopathies.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON37561

Enrollment

Registered

2012-03-14

Start date

2012-09-06

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

Congenital thrombocytopathy hereditary platelet disorder

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) Confirmed diagnosis of Storage Pool Disease or other hereditary thrombocytopathy. 2) 18 years of age or older

Exclusion criteria

Exclusion criteria: 1) Uncertainty about diagnosis expressed by their treating physician. 2) Use of medication that is known to influence platelets such as acetylsalicylic acid, clopidogrel, dipyridamole and NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) within 14 days prior to inclusion. 3) Younger than the age of 18.

Design outcomes

Primary

Measure	Time frame
1) Platelet reactivity with increasing concentrations of agonist with or without an added constant concentration of antagonist. Activation is measured with Fluorescence Activated Cell Sorting (FACS) analysis and expressed in percentage positive, Median Fluorescence Intensity (MFI), the concentration of agonist which leads to half maximum effect (EC50) and Area Under the dose response Curve (AUC). 2) Platelet aggregate formation measurements will be performed using a perfusion flow model. The main steps in platelet aggregate formation (adhesion, aggregation and spreading) will be studied and quantified.	—

Measure

Time frame

1) Platelet reactivity with increasing concentrations of agonist with or without an added constant concentration of antagonist. Activation is measured with Fluorescence Activated Cell Sorting (FACS) analysis and expressed in percentage positive, Median Fluorescence Intensity (MFI), the concentration of agonist which leads to half maximum effect (EC50) and Area Under the dose response Curve (AUC). 2) Platelet aggregate formation measurements will be performed using a perfusion flow model. The main steps in platelet aggregate formation (adhesion, aggregation and spreading) will be studied and quantified.

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Secondary

Measure	Time frame
The secondary parameter/outcome is to study the correlation between the newly developed the ISTH/SSC Bleeding Assessment Tool and outcomes of FACS and Perfusion measurements.	—

Countries

Netherlands

Outcome results