Menu
Recruiting NCT06212635

Hemostasis in Liver Cirrhosis and Hepatocellular Cancer

— Observational Hemostasis in Decompensated Liver Cirrhosis Inflammation in Decompensated Liver Cirrhosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: T-TAS.
Who it may be relevant to
Registry conditions: Hemostasis in Decompensated Liver Cirrhosis, Inflammation in Decompensated Liver Cirrhosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Novel Biomarkers for Evaluation of Hemostasis and Inflammation in Liver Cirrhosis

Overview

Evaluating hemostasis in decompensated liver cirrhosis with novel hemostatic assays.

Detailed 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.

Interventions

  • Diagnostic test T-TAS
    Blood test, laboratory assays

Primary outcome measures

  • Differences in laboratory values between groupstests [Time frame: up to 5 years]
  • Correlation between systemic inflammation and hemostasis measured by novel assays [Time frame: uo to 7 years]
Secondary outcome measures (4)
  • Number of participant with bleeding [Time frame: Up to 7 years]
  • Number of participants with Thrombosis [Time frame: Up to 7 years]
  • Number of participants that die [Time frame: Up to 7 years]
  • Number of participant going to transplant [Time frame: Up to 7 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Sweden · 1 center
  • Karolinska University Hospital — Stockholm

Identifiers

NCT: NCT06212635 · 2020-00316200610

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗