Clinical trial NCT02361294: Immature Plateletes in the Etiopathology of Deep Venous Thrombosis
Official title: Prospective Study to Generate Hypotheses About the Role of Platelets and Immature Platelets in the Pathogenesis of Idiopathic Venous Thromboses and Pulmonary Embolisms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immature Platelets
Deep Venous Thrombosis
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2015-02-11
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all-comers

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.


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

Primary outcomes:
measure: Significantly increased proportion of immature platelets in patients with deep venous thrombosis and/or pulmonary embolism compared to the control.
timeFrame: at time of diagnosis
Secondary outcomes:
measure: Significantly higher values of platelet function in patients with deep venous thrombosis and/or pulmonary embolism compared to the control.
timeFrame: at time of diagnosis
measure: 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.
timeFrame: 3 months after diagnosis
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum rechts der Isar, Technische Universität München
Study officials:
affiliation: Senior consultant
name: Tareq Ibrahim, MD
role: PRINCIPAL_INVESTIGATOR
References: