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NCT01169168 Clinical Trial

Measurement of Fibrinogen in Patients With Systemic Inflammatory Response Syndrome (SIRS), Sepsis or Chronicle Liver Disease on Intensive Care Units (ICU)

Sepsis Clinical Trial

Official title:
Measurement of Fibrinogen in Patients With Systemic Inflammatory Response Syndrome, Sepsis, Chronicle Liver Disease or After Lysis on Intensive Care Units

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01169168
Other study ID # FibICU
Secondary ID
Status Recruiting
Phase N/A
First received July 23, 2010
Last updated July 23, 2010
Start date April 2010

Study information
Verified date July 2010
Source Johann Wolfgang Goethe University Hospitals
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial Summary

In this study patients with

1. chronicle liver diseases

- primary biliary cirrhosis

- primary sclerosing cholangitis

- alcoholic liver cirrhosis

- hepatitis b or C

- Wilson's disease

- cryptogenic cirrhosis

2. Septic Inflammatory Response Syndrome (SIRS)

- sepsis

- septic shock

3. patients after lysis

should be included

Blood samples will be gathered from the patients to measure fibrinogen with 5 different methods.

The methods are:

- Clauss fibrinogen

- PT-Derived fibrinogen

- immunoturbidimetric method

- heat-precipitated fibrinogen

- Schulz fibrinogen

The result of these tests will be correlated with laboratory values which are gathered in routine and the clinical outcomes.

Recruitment information / eligibility
Status Recruiting
Enrollment 250
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- SIRS

- sepsis

- septic shock

- chronicle liver disease (MELD-Score >10)

- patient after lysis

- patient agrees

Exclusion Criteria:

- no agreement

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Johann Wolfgang Goethe University Hospital Frankfurt Hessen

Sponsors (1)
Lead Sponsor Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fibrinogen levels from 5 test methods Clauss fibrinogen
PT-Derived fibrinogen
immunoturbidimetric method
heat-precipitated fibrinogen
Schulz fibrinogen		 No
Secondary Number of bleedings
Secondary Number of administered fresh frozen plasma
Secondary Number of administered erythrocyte concentrates
Secondary Number of administered thrombocyte concentrates
Secondary mortality
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