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

Venous Thromboembolism Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01744431
• Other study ID #: thrombin generation
• Status: Completed
• Phase: N/A
• First received: December 5, 2012
• Last updated: December 15, 2015
• Start date: December 2012
• Est. completion date: September 2013

Study information

• Verified date: December 2015
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• signed inform consent

Exclusion Criteria:

• pregnant women

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Locations

Country	Name	City	State
Israel	Emek medical center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	venous thromboembolism		1 week	No