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

NCT01169168 | Unknown

• 1 other identifier: FibICU
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

In this study patients with

• primary biliary cirrhosis
• primary sclerosing cholangitis
• alcoholic liver cirrhosis
• hepatitis b or C
• Wilson's disease
• cryptogenic cirrhosis
• Septic Inflammatory Response Syndrome (SIRS)
• sepsis
• septic shock
• patients after lysis
• 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.

Conditions

SIRS; Sepsis; Liver Disease

Keywords

fibrinogen; SIRS; sepsis; liver disease; chronic liver disease; septic shock

Outcome Measures

Primary Outcomes (1)

• Fibrinogen levels from 5 test methods

  * Clauss fibrinogen * PT-Derived fibrinogen * immunoturbidimetric method * heat-precipitated fibrinogen * Schulz fibrinogen

Secondary Outcomes (5)

• Number of bleedings

• Number of administered fresh frozen plasma

• Number of administered erythrocyte concentrates

• Number of administered thrombocyte concentrates

• mortality

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients in intensive care units of the university hospital

You may qualify if:

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

You may not qualify if:

• no agreement

Sponsors & Collaborators

• Johann Wolfgang Goethe University Hospital: lead

Study Sites (1)

Johann Wolfgang Goethe University Hospital

Frankfurt am Main, Hesse, 60590, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

citrated plasma

MeSH Terms

Conditions

Sepsis; Liver Diseases; Shock, Septic

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Diseases; Shock

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 23, 2010
• First Posted: July 26, 2010
• Study Start: April 1, 2010
• Last Updated: July 26, 2010

Record last verified: 2010-07

Locations

DE (1)