Deep Venous Thrombosis, Immature Platelets
Conditions
Brief summary
The study is designed to evaluate the role of platelets and immature platelets in the ethiopathology of deep venous thrombosis and pulmonary embolism.
Interventions
OTHERBlood samples
Sponsors
Technical University of Munich
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Germany
Outcome results
None listed