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

Technical University of Munich1 site in 1 country72 target enrollmentDecember 2014

ConditionsImmature Platelets Deep Venous Thrombosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Immature Platelets
Sponsor: Technical University of Munich
Enrollment: 72
Locations: 1
Primary Endpoint: Significantly increased proportion of immature platelets in patients with deep venous thrombosis and/or pulmonary embolism compared to the control.
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2014

End Date

July 2018

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Technical University of Munich

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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

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)