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Completed

NCT Number: NCT02361294

Immature Plateletes in the Etiopathology of Deep Venous Thrombosis

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

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Key information

Conditions

Immature Platelets Cardiovascular Diseases Deep Venous Thrombosis Embolism and Thrombosis Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum rechts der Isar, Technische Universität München

Munich, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Samples

Other

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Official study title

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

Acronym: iPLATELET

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Feb 11, 2015
Registry last updated
Aug 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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