SIRSNCT01169168
Measurement of Fibrinogen in Patients With Systemic Inflammatory Response Syndrome (SIRS), Sepsis or Chronicle Liver Disease on Intensive Care Units (ICU)
An observational study of SIRS and Sepsis, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- SIRS, Sepsis, Liver Disease
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2010to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients in intensive care units of the university hospital
Who may be able to join
- SIRS
- sepsis
- septic shock
- chronicle liver disease (MELD-Score >10)
- patient after lysis
- patient agrees
Who cannot join
- no agreement
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Johann Wolfgang Goethe University Hospital
Frankfurt am Main, Hesse, 60590
Wolfgang Miesbach, +49696301 ext. 7788, wolfgang.miesbach@kgu.de
Alexander Ferlemann, ferleman@stud.uni-frankfurt.de
About this study
Official title: 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
- chronicle liver diseases
- 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 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.
- Conditions
- SIRS, Sepsis, Liver Disease
- Keywords
- fibrinogen, SIRS, sepsis, liver disease, chronic liver disease, septic shock
- Medical subject headings
- Sepsis, Liver Diseases, Shock, Septic
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
- Study startApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SIRSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169168
- Sponsor's protocol ID
- FibICU
- Status last verified
- Jul 2010
- First submitted
- 23 Jul 2010
- Last updated
- 26 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Fibrinogen in Patients With Systemic Inflammatory Response Syndrome, Sepsis, Chronicle Liver Disease or After Lysis on Intensive Care Units
- ClinicalTrials.gov ID
- NCT01169168
- Acronym / sponsor ID
- FibICU
- Conditions
- SIRS, Sepsis, Liver Disease
- Keywords
- fibrinogen, SIRS, sepsis, liver disease, chronic liver disease, septic shock
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Apr 2010
- First posted
- 26 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study patients with
- chronicle liver diseases
- 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 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients in intensive care units of the university hospital
Key inclusion criteria (6 listed)
- SIRS
- sepsis
- septic shock
- chronicle liver disease (MELD-Score >10)
- patient after lysis
Key exclusion criteria (1 listed)
- no agreement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fibrinogen levels from 5 test methods
* Clauss fibrinogen * PT-Derived fibrinogen * immunoturbidimetric method * heat-precipitated fibrinogen * Schulz fibrinogen
5 secondary outcomes
Number of bleedings
Number of administered fresh frozen plasma
Number of administered erythrocyte concentrates
Number of administered thrombocyte concentrates
mortality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johann Wolfgang Goethe University Hospital
Frankfurt am Main, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SIRS and Sepsis, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibrinogen levels from 5 test methods. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2010.