Immature Plateletes in the Etiopathology of Deep Venous Thrombosis

Overview

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

Full Title of Study: “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

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 7, 2017

Interventions

  • Other: Blood samples

Arms, Groups and Cohorts

  • Patient
    • 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.
  • Control
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Significantly increased proportion of immature platelets in patients with deep venous thrombosis and/or pulmonary embolism compared to the control.
    • Time Frame: at time of diagnosis

Secondary Measures

  • Significantly higher values of platelet function in patients with deep venous thrombosis and/or pulmonary embolism compared to the control.
    • Time Frame: 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.
    • Time Frame: 3 months after diagnosis

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Technical University of Munich
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Tareq Ibrahim, MD, Principal Investigator, Senior consultant

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