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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Johann Wolfgang Goethe University Hospitals.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01169168
First received: July 23, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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.


Condition
SIRS
Sepsis
Liver Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measurement of Fibrinogen in Patients With Systemic Inflammatory Response Syndrome, Sepsis, Chronicle Liver Disease or After Lysis on Intensive Care Units

Resource links provided by NLM:

Drug Information available for: Fibrinogen
U.S. FDA Resources

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Fibrinogen levels from 5 test methods [ Designated as safety issue: No ]
    • Clauss fibrinogen
    • PT-Derived fibrinogen
    • immunoturbidimetric method
    • heat-precipitated fibrinogen
    • Schulz fibrinogen


Secondary Outcome Measures:
  • Number of bleedings
  • Number of administered fresh frozen plasma
  • Number of administered erythrocyte concentrates
  • Number of administered thrombocyte concentrates
  • mortality

Biospecimen Retention:   Samples Without DNA

citrated plasma


Estimated Enrollment: 250
Study Start Date: April 2010
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients in intensive care units of the university hospital

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • no agreement
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01169168

Locations
Germany
Johann Wolfgang Goethe University Hospital Recruiting
Frankfurt, Hessen, Germany, 60590
Contact: Wolfgang Miesbach     +49696301 ext 7788     wolfgang.miesbach@kgu.de    
Contact: Alexander Ferlemann         ferleman@stud.uni-frankfurt.de    
Principal Investigator: Wolfgang Misbach            
Sub-Investigator: Carola Hecking            
Sub-Investigator: Alexander Ferlemann            
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
  More Information

No publications provided

Responsible Party: Dr. med. Wolfgang Miesbach, Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT01169168     History of Changes
Other Study ID Numbers: FibICU
Study First Received: July 23, 2010
Last Updated: July 23, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by Johann Wolfgang Goethe University Hospitals:
fibrinogen
SIRS
sepsis
 liver disease
chronic liver disease
septic shock

Additional relevant MeSH terms:
Liver Diseases
Sepsis
Toxemia
Systemic Inflammatory Response Syndrome
Digestive System Diseases
 Infection
Inflammation
Pathologic Processes
Shock

ClinicalTrials.gov processed this record on October 17, 2012