end-stage liver disease liverfibrosis
Conditions
Interventions
None listed
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
Exclusion criteria: Patients: - Malignancy;Controls: - Malignancy - Auto-immune disease - Documentation of inherited bleeding disorders - Cirrhosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| This study will measure the percentual difference of ex vivo thrombin generation capacity of plasma before and after anticoagulation compared to patients without cirrhosis. The primary endpoint is the difference between anticoagulant potency (as expressed by percentual decrease in thrombin generation) of prophylactic or therapeutic anticoagulation in patients versus controls. | — |
Secondary
| Measure | Time frame |
|---|---|
| Other study parameters that will be observed are the incidence of bleeding and thrombosis untill 3 months after the event or admission. This information will be gathered from the patients* medical chart. If present data on the resolution of thrombosis during or after anticoagulant treatment will be collected (max 3 months). Also information on previous thrombotic events and previous use of anticoagulants will be collected. Prothrombin time, activated partial thromboplastin time, factor II, I and Xa-activity will be measured from the same samples of which the thrombin generation capacity is tested. | — |
Countries
Netherlands
Outcome results
None listed