Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT02361294
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02361294
Study Brief:
Protocol Section:
NCT02361294