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Can Thrombin Generation Measurement Predict the Risk of Venous Thromboembolism in Acute Ill Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01744431
First Posted: December 6, 2012
Last Update Posted: December 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Elias mazen, HaEmek Medical Center, Israel
  Purpose

Can thrombin generation measurement predict the risk of venous thromboembolism in acute ill patients

Traditional coagulation tests do not assess the whole coagulation system. Thrombin generation assays measure the ability of plasma sample to generate thrombin following in vitro activation of coagulation. In contrast to the classical clotting assays, thrombin generation reflects and integrates all pro and anticoagulant reactions that regulate the formation and inhibition of thrombin.

The aim of our study is to investigate whether thrombin generation would be able to predict a hypercoagulable state in acute ill patients admitted in the internal medical departments and how it correlates with the Padua prediction score, a score that could assists the risk for venous thromboembolism in hospitalized medical patients.

In total 300 patients are planned for inclusion in this trial. After signing an informed consent a blood sample will be obtained from each participant. We will measure the thrombin generation over time in plasma assessed by the calibrated automated thrombogram (CAT).


Condition
Venous Thromboembolism

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day

Further study details as provided by Elias mazen, HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • venous thromboembolism [ Time Frame: 1 week ]

Enrollment: 400
Study Start Date: December 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
No treatment

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
300 hospitalized patients
Criteria

Inclusion Criteria:

  • signed inform consent

Exclusion Criteria:

  • pregnant women
  Contacts and Locations
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): NCT01744431


Locations
Israel
Emek medical center
Afula, Israel
Sponsors and Collaborators
HaEmek Medical Center, Israel
Investigators
Principal Investigator: mazen elias, MD Emek medical center
  More Information

Responsible Party: Elias mazen, Director of Internal Medicine, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01744431     History of Changes
Other Study ID Numbers: thrombin generation
First Submitted: December 5, 2012
First Posted: December 6, 2012
Last Update Posted: December 16, 2015
Last Verified: December 2015

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