Immature Plateletes in the Etiopathology of Deep Venous Thrombosis

NCT02361294 | Completed

• 1 other identifier: TechnischeUM 1
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (2)

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

Interventions

Blood samples OTHER

Control; Patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

all-comers

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

Klinikum rechts der Isar, Technische Universität München

Munich, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

thrombophilia screening

MeSH Terms

Conditions

Venous Thrombosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Tareq Ibrahim, MD

  Senior consultant

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2015
• First Posted: February 11, 2015
• Study Start: December 1, 2014
• Primary Completion: April 7, 2017
• Study Completion: July 1, 2018
• Last Updated: August 13, 2018

Record last verified: 2018-08

Locations

DE (1)