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CHANGES IN THE COAGULATION CASCADE IN PATIENTS WITH PROGRESSIVE (METABOLIC) LIVERDISEASE

CHANGES IN THE COAGULATION CASCADE IN PATIENTS WITH PROGRESSIVE (METABOLIC) LIVERDISEASE - TG-study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON36796
Enrollment
140
Registered
2010-03-01
Start date
2010-03-12
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

liver cirrhosis liver scarring

Interventions

None listed

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy controls (population A): - minimum age of 18-years old - decision making capacity;Patients (group B) (minimum of 18 years old) with cirrhosis, as diagnosed by a GE-specialist, due to one of the following chronic liver diseases: Primary Biliairy Sclerosis (PBS), Primary Sclerosis Cholangitis (PSC), Hepatitis B, Hepatitis C, Non-Alcoholic Fatty Liver Disease (NAFLD), Alcoholic Liverdisease, Non-Alcoholic Steatosis Hepatitis (NASH), Haemochromatosis, Cryptogenic levercirrhosis.

Exclusion criteria

Exclusion criteria: For both healthy controls (population A) as patients (population B): - proven congenital diseases concerning primary hemostasis (e.g. M. von Willebrand), defects in fibrinolysis, coagulation factor deficiencies (e.g. hemophilia A and B), vasculair defects which leed to higher bleeding risk (e.g. M. Rendu-Osler-Weber). Patients using medication interfering with primary hemostasis or coagulation. Coagulation factor deficiencies due to malignancies, sepsis or trauma.

Design outcomes

Primary

MeasureTime frame
Thrombin Generation Curve in PPP (platelet poor plasma) and PRP (platelet rich plasma) using CAT Thrombocyte function test using the Multiplate (aggregometer) Measurement of the fibronolysis pathway by use of the Fibrinolysis ROTEM Measurement of microparticles with influence on the haemostasis.

Secondary

MeasureTime frame
Coagulatie parameters o Factor II o Factor VIII o Antitrombin

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)