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

• Conditions: SIRS; Liver Disease; Sepsis

• Registration Number: NCT01169168
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Status Verified: 2010-07
• Study First Submitted: 2010-07-23
• Study First Submitted QC: 2010-07-23
• Last Update Submitted: 2010-07-23
• Study First Posted: 2010-07-26
• Last Update Posted: 2010-07-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• SIRS
• sepsis
• septic shock
• chronicle liver disease (MELD-Score >10)
• patient after lysis
• patient agrees

Exclusion Criteria

• no agreement

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fibrinogen levels from 5 test methods		* Clauss fibrinogen; * PT-Derived fibrinogen; * immunoturbidimetric method; * heat-precipitated fibrinogen; * Schulz fibrinogen

Secondary Outcome Measures

Name	Time	Method
Number of bleedings
Number of administered thrombocyte concentrates
Number of administered erythrocyte concentrates
Number of administered fresh frozen plasma
mortality

Trial Locations

Locations (1)

Johann Wolfgang Goethe University Hospital; 🇩🇪 Frankfurt, Hessen, Germany