Immature Plateletes in the Etiopathology of Deep Venous Thrombosis

Completed

• Conditions: Immature Platelets; Deep Venous Thrombosis
• Interventions: Other: Blood samples

• Registration Number: NCT02361294
• Lead Sponsor: Technical University of Munich

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-02-06
• Study First Submitted QC: 2015-02-10
• Study First Posted: 2015-02-11
• Primary Completion: 2017-04-07
• Study Completion: 2018-07
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-10
• Last Update Posted: 2018-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient	Blood samples	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	Blood samples	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Klinikum rechts der Isar, Technische Universität München; 🇩🇪 Munich, Germany