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Immature Plateletes in the Etiopathology of Deep Venous Thrombosis (iPLATELET)

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ClinicalTrials.gov Identifier: NCT02361294
Recruitment Status : Unknown
Verified February 2015 by Technische Universität München.
Recruitment status was:  Recruiting
First Posted : February 11, 2015
Last Update Posted : February 11, 2015
Sponsor:
Information provided by (Responsible Party):
Technische Universität München

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.

Condition or disease Intervention/treatment
Immature Platelets Deep Venous Thrombosis Other: Blood samples

Study Type : Observational
Estimated Enrollment : 100 participants
Time Perspective: Prospective
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
Study Start Date : December 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Other: Blood samples
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.
Other: Blood samples



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
thrombophilia screening


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
all-comers
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02361294


Contacts
Contact: Tareq Ibrahim, MD 0049 89 4140 2350 t.ibrahim@lrz.tu-muenchen.de
Contact: Nicolas Langwieser, MD 0049 89 4140 2350 nicolaslangwieser@web.de

Locations
Germany
Klinikum rechts der Isar, Technische Universität München Recruiting
Munich, Germany
Contact: Tareq Ibrahim, MD    0049 89 4140 2350    t.ibrahim@lrz.tu-muenchen.de   
Sponsors and Collaborators
Technische Universität München
Investigators
Principal Investigator: Tareq Ibrahim, MD Senior consultant

Responsible Party: Technische Universität München
ClinicalTrials.gov Identifier: NCT02361294     History of Changes
Other Study ID Numbers: TechnischeUM 1
First Posted: February 11, 2015    Key Record Dates
Last Update Posted: February 11, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases