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NCT02953002 Clinical Trial

The Correlation Between The New Sepsis Scores - SOFA, Quick SOFA and Calibrated Automated Thrombogram Values

Sepsis Clinical Trial

Official title:
The Correlation Between The New Sepsis Scores - SOFA, Quick SOFA and Calibrated Automated Thrombogram Values

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02953002
Other study ID # EMC131-16
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 17, 2017
Est. completion date September 2021

Study information
Verified date August 2022
Source HaEmek Medical Center, Israel
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In total 200 subjects with diagnosis of sepsis, are planned for inclusion in this trial. After signing an informed consent a blood sample will be obtained from each participant. The investigators will measure the thrombin generation in plasma assessed by the calibrated automated thrombogram (CAT). Sequential Organ Failure Assessment score SOFA will be calculated. The relation between SOFA score and thrombin measurements will be determined.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date September 2021
Est. primary completion date September 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - age above 18 - sepsis diagnosis Exclusion Criteria: - oncology patient. - anticoagulant treatment - pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Calibrated Automated Thrombogram (CAT)
The Calibrated Automated Thrombogram (CAT). Thrombogram describes the concentration of thrombin in clotting plasma and is therefore a general physiologic function test of the thrombotic hemostatic system. The CAT measures thrombotic as well as bleeding tendency.

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 correlation between sofa score and thrombin generation one week
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