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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elias mazen, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT01744431
First received: December 5, 2012
Last updated: March 24, 2014
Last verified: March 2014
  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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • venous thromboembolism [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 5, 2012
Last Updated: March 24, 2014
Health Authority: Israel: Ethics Commission

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

ClinicalTrials.gov processed this record on July 28, 2014