We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by Johann Wolfgang Goethe University Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01169168
First Posted: July 26, 2010
Last Update Posted: July 26, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Johann Wolfgang Goethe University Hospital
  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:


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

Primary Outcome Measures:
  • Fibrinogen levels from 5 test methods
    • 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Hospital
  More Information

Responsible Party: Dr. med. Wolfgang Miesbach, Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT01169168     History of Changes
Other Study ID Numbers: FibICU
First Submitted: July 23, 2010
First Posted: July 26, 2010
Last Update Posted: July 26, 2010
Last Verified: July 2010

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

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