Hemostasis in Liver Cirrhosis and Hepatocellular Cancer (HELICS)

Region Stockholm

Status: Enrolling

Conditions: Inflammation in Decompensated Liver Cirrhosis; Hemostasis in Decompensated Liver Cirrhosis

Treatments: Diagnostic Test: T-TAS

Study type: Observational

Funder types: Other

Identifiers

NCT06212635

2020-00316200610

Details and patient eligibility

About

Evaluating hemostasis in decompensated liver cirrhosis with novel hemostatic assays.

Full description

The rebalanced hemostasis in liver cirrhosis is vulnerable and patients are prone to both bleeding and thrombosis. There are today no gold standard for evaluating the hemostasis and we will evaluate novel methods for this.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with decompensated liver cirrhosis
• 18 years or older.
• Healthy individuals 18 years or older will serve as controls.

Exclusion criteria

• • Extrahepatic malignancy or recurrence of such within the last year.

  • Diagnosis of non-cirrhotic coagulopathy, coagulation disorder or thrombophilia prior to inclusion.
  • Diagnosis of hematological disease such as hematologic malignancies, non-cirrhotic thrombocytopenia or thrombocytosis, Polycytemia Vera, hemoglobinopathies
  • Previous liver transplantation.
  • Transfusions the last 7 days.
  • Treatment with platelet inhibitors or anticoagulant except for prophylactic dosage of LMWH. If a prophylactic dose of LMWH has been used study sampling with addition of antiFXa must be taken >12 hours after the last injection.

Trial design

100 participants in 4 patient groups

Non-acute decompensated liver círrhosis

Description:

Refractory ascites, low grade encephalopathy but manages to stay at home and only come in ofr check-ups.

Treatment:

Diagnostic Test: T-TAS

Acute decompensated liver cirrhosis

Description:

Acute event causing further decompensation and the need for in-patient care

Treatment:

Diagnostic Test: T-TAS

Acute on chronic liver failure

Description:

ACLF 1-3 accordic to criterias established through the Cannonic study.

Treatment:

Diagnostic Test: T-TAS

Controls

Description:

Healthy individuals

Treatment:

Diagnostic Test: T-TAS