Immature Plateletes in the Etiopathology of Deep Venous Thrombosis

Study Overview
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Brief Summary
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The study is designed to evaluate the role of platelets and immature platelets in the ethiopathology of deep venous thrombosis and pulmonary embolism.

Official Title
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Prospective Study to Generate Hypotheses About the Role of Platelets and Immature Platelets in the Pathogenesis of Idiopathic Venous Thromboses and Pulmonary Embolisms

Conditions
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Immature Platelets, Deep Venous Thrombosis

Intervention / Treatment
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* Other: Blood samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a newly diagnosed deep venous thrombosis and/or pulmonary embolism. The thrombembolism is idiopathic or caused by immobilisation. Control: Patients that present with a suspicion of deep venous thrombosis which is excluded by duplex sonography. Exclusion Criteria: therapy with glycoprotein IIb/IIIa-antagonists within the last 10 days therapy with antiplatelet drugs (ASA, Clopidogrel, Ticagrelor, Prasugrel, Dipyridamol) preexisting anticoagulation number of platelets < 100.000/µl anemia (hematocrit < 35%, Hb < 10 g/dl) age > 80 y or < 18 y renal insufficiency GFR < 30 ml/min hepatic impairment with an increased risk for bleeding or coagulopathy, or liver cirrhosis (≥ Child Pugh B) intracranial or intracerebral bleeding within the last six months intraspinal or intracerebral vascular anomalies clinically relevant acute bleedings malign disease infections within the last 7 d hematological, rheumatologic and autoimmune diseases operations within the last six months transfusion of rec celll concentrates within the last six months transfusion of fresh frozen plasma or platelet concentrates within the last month preexisting medication with CYP 3A4 inhibitors and inductors, p-glycoprotein inhibitors (Azol-Antimycotis, HIV protease-inhibitors) hypersensitivity/contraindications for Rivaroxaban pregnancy or lactation thrombophilia thrombocytopathy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient<br>Patients with a newly diagnosed deep venous thrombosis and/or pulmonary embolism. The thrombembolism is idiopathic or caused by immobilisation. Three blood samples are taken during the study period. A thrombophilia screening is carried out. | Other: Blood samples<br> <br> |
| Control<br>Patients that present with a suspicion of deep venous thrombosis which is excluded by duplex sonography. One to two blood samples are taken during the study period. | Other: Blood samples<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significantly increased proportion of immature platelets in patients with deep venous thrombosis and/or pulmonary embolism compared to the control. |  | at time of diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significantly higher values of platelet function in patients with deep venous thrombosis and/or pulmonary embolism compared to the control. |  | at time of diagnosis | 
| A persistently increased proportion of immature platelets in patients with deep venous thrombosis and/or pulmonary embolism compared to the controls three months after diagnosis. |  | 3 months after diagnosis |