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

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. Identifier: NCT01744431
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : December 16, 2015
Information provided by (Responsible Party):
Elias mazen, HaEmek Medical Center, Israel

Brief Summary:

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 or disease
Venous Thromboembolism

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Study Type : Observational [Patient Registry]
Actual Enrollment : 400 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Study Start Date : December 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

No treatment

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

Information from the National Library of Medicine

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

Inclusion Criteria:

  • signed inform consent

Exclusion Criteria:

  • pregnant women

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 identifier (NCT number): NCT01744431

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

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Responsible Party: Elias mazen, Director of Internal Medicine, HaEmek Medical Center, Israel Identifier: NCT01744431    
Other Study ID Numbers: thrombin generation
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: December 16, 2015
Last Verified: December 2015
Additional relevant MeSH terms:
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Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases