Immature Plateletes in the Etiopathology of Deep Venous Thrombosis

Deep Venous Thrombosis Clinical Trial

— iPLATELET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02361294
• Other study ID #: TechnischeUM 1
• Status: Completed
• Start date: December 2014
• Est. completion date: July 2018

Study information

• Verified date: August 2018
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: July 2018
• Est. primary completion date: April 7, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Venous Thrombosis
• Immature Platelets
• Thrombosis
• Venous Thrombosis

Intervention

Other:
• Blood samples

Locations

Country	Name	City	State
Germany	Klinikum rechts der Isar, Technische Universität München	Munich

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Significantly higher values of platelet function in patients with deep venous thrombosis and/or pulmonary embolism compared to the control.		at time of diagnosis
Secondary	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