Current use of anticoagulants in cirrhosis: a prospective study.

Completed

Conditions: end-stage liver disease
liverfibrosis
10064477
10019654

Registration Number: NL-OMON43138

Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 300

Inclusion Criteria

Patients:
- Age over 18 yrs
- Diagnosed with cirrhosis according to one of the following criteria:
a Fibroscan suggestive for F4 fibrosis
b Histology compatible with severe fibrosis (Metavir F4)
c Physician*s reports
- Written informed consent
- (Future) indication to start anticoagulant therapy (prophylactic or therapeutic) ;Controls:
- Age over 18 yrs
- Written informed consent
- Indication to start anticoagulant therapy (prophylactic or therapeutic)

Exclusion Criteria

Patients:
- Malignancy;Controls:
- Malignancy
- Auto-immune disease
- Documentation of inherited bleeding disorders
- Cirrhosis

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>This study will measure the percentual difference of ex vivo thrombin<br /><br>generation capacity of plasma before and after anticoagulation compared to<br /><br>patients without cirrhosis. The primary endpoint is the difference between<br /><br>anticoagulant potency (as expressed by percentual decrease in thrombin<br /><br>generation) of prophylactic or therapeutic anticoagulation in patients versus<br /><br>controls. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Other study parameters that will be observed are the incidence of bleeding and<br /><br>thrombosis untill 3 months after the event or admission. This information will<br /><br>be gathered from the patients* medical chart. If present data on the resolution<br /><br>of thrombosis during or after anticoagulant treatment will be collected (max 3<br /><br>months). Also information on previous thrombotic events and previous use of<br /><br>anticoagulants will be collected. Prothrombin time, activated partial<br /><br>thromboplastin time, factor II, I and Xa-activity will be measured from the<br /><br>same samples of which the thrombin generation capacity is tested. </p><br>