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

July 23, 2010 updated by: Johann Wolfgang Goethe University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • Recruiting
        • Johann Wolfgang Goethe University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wolfgang Misbach
        • Sub-Investigator:
          • Carola Hecking
        • Sub-Investigator:
          • Alexander Ferlemann

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients in intensive care units of the university hospital

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • no agreement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Fibrinogen levels from 5 test methods
  • Clauss fibrinogen
  • PT-Derived fibrinogen
  • immunoturbidimetric method
  • heat-precipitated fibrinogen
  • Schulz fibrinogen

Secondary Outcome Measures

Outcome Measure
mortality
Number of bleedings
Number of administered fresh frozen plasma
Number of administered erythrocyte concentrates
Number of administered thrombocyte concentrates

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Study Registration Dates

First Submitted

July 23, 2010

First Submitted That Met QC Criteria

July 23, 2010

First Posted (Estimate)

July 26, 2010

Study Record Updates

Last Update Posted (Estimate)

July 26, 2010

Last Update Submitted That Met QC Criteria

July 23, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FibICU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sepsis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Denmark

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe