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

NCT ID: NCT01744431

Last Updated: 2015-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2013-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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Venous Thromboembolism

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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No treatment

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* signed inform consent

Exclusion Criteria

* pregnant women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Elias mazen

Director of Internal Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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mazen elias, MD

Role: PRINCIPAL_INVESTIGATOR

Emek Medical Center

Locations

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Emek medical center

Afula, , Israel

Site Status

Countries

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Israel

Other Identifiers

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thrombin generation

Identifier Type: -

Identifier Source: org_study_id