The effect of anagrelide and hydroxyurea on platelet function in patients with Essential Thrombocytosis. An observational in vitro and ex vivo study on the dynamic conditions of platelet function and (systemic) coagulation activation.

The effect of anagrelide and hydroxyurea on platelet function in patients with Essential Thrombocytosis. An observational in vitro and ex vivo study on the dynamic conditions of platelet function and (systemic) coagulation activation. - The effect of anagrelide and hydroxyurea on platelet function.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON35998

Enrollment

Registered

2011-11-24

Start date

2012-11-01

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

Thrombocythemia or primary thrombocytosis (no laymen's term)

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Essential Thrombocytosis, diagnostic criteria met by the WHO criteria. - According to the studied patient group, included patients will either use no cytoreductive therapy, or already use hydroxyurea or anagrelide. Or they will start treatment with hydroxyurea or anagrelide within two months. - Age18 years or older

Exclusion criteria

Exclusion criteria: - Use of medication that is known to influence platelet function (other than acetylsalicylic acid), s.a. clopidogrel, dipyridamole and NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) within 14 days prior to inclusion and during follow up.

Design outcomes

Primary

Measure	Time frame
The primary study parameters of this study are; 1. Platelet reactivity (FACS analysis - static conditions) 2. Platelet aggregate formation (perfusion model - dynamic conditions)	—

Secondary

Measure	Time frame
The secondary study parameters of this study are; 1. The effect of in vitro addition of anagrelide, BCH4426 (the metabolite of anagrelide) and hydroxyurea on the platelet reactivity. 2. Markers of systemic platelet activation - Soluble P-selectin (sPsel) - Soluble CD-40 ligand (sCD40L) - Regulated upon Activation, Normal T cell Expressed and Secreted (RANTES) - Neutrophil Activating Protein-2 (CXCL7) - Microparticles - Von Willebrand Factor (vWF) 3. Markers of systemic coagulation activation - Prothrombin fragment 1+2 - Thrombin-Antithrombin (TAT)-complexes - Fibrine monomers - D-dimers 4. Platelet-monocyte complex formation	—

Measure

Time frame

The secondary study parameters of this study are; 1. The effect of in vitro addition of anagrelide, BCH4426 (the metabolite of anagrelide) and hydroxyurea on the platelet reactivity. 2. Markers of systemic platelet activation - Soluble P-selectin (sPsel) - Soluble CD-40 ligand (sCD40L) - Regulated upon Activation, Normal T cell Expressed and Secreted (RANTES) - Neutrophil Activating Protein-2 (CXCL7) - Microparticles - Von Willebrand Factor (vWF) 3. Markers of systemic coagulation activation - Prothrombin fragment 1+2 - Thrombin-Antithrombin (TAT)-complexes - Fibrine monomers - D-dimers 4. Platelet-monocyte complex formation

—

Countries

Netherlands

Outcome results