Immature Plateletes in the Etiopathology of Deep Venous Thrombosis

NCT ID: NCT02361294

Last Updated: 2018-08-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 72 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2018-07-31

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.

Conditions

Immature Platelets; Deep Venous Thrombosis

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Blood samples

Intervention Type: OTHER

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.

Blood samples

Intervention Type: OTHER

Interventions

Blood samples

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Technical University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tareq Ibrahim, MD

Role: PRINCIPAL_INVESTIGATOR

Senior consultant

Locations

Klinikum rechts der Isar, Technische Universität München

Munich, , Germany

Countries

Germany

Other Identifiers

TechnischeUM 1

Identifier Type: -

Identifier Source: org_study_id