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

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ClinicalTrials.gov Identifier: NCT01744431
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : December 16, 2015
Sponsor:
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

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

Group/Cohort
No treatment



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


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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
Criteria

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 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

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 Posted: December 6, 2012    Key Record Dates
Last Update Posted: December 16, 2015
Last Verified: December 2015

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