Hemostasis in Liver Cirrhosis and Hepatocellular Cancer

Recruiting

• Conditions: Hemostasis in Decompensated Liver Cirrhosis; Inflammation in Decompensated Liver Cirrhosis
• Interventions: Diagnostic Test: T-TAS

• Registration Number: NCT06212635
• Lead Sponsor: Region Stockholm

Brief Summary

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.

Study Timeline

• Study Start: 2022-12-02
• Status Verified: 2023-02
• Study First Submitted: 2023-02-22
• Study First Submitted QC: 2024-01-08
• Last Update Submitted: 2024-01-08
• Study First Posted: 2024-01-19
• Last Update Posted: 2024-01-19
• Primary Completion: 2026-12-01
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Acute on chronic liver failure	T-TAS	ACLF 1-3 accordic to criterias established through the Cannonic study.
Controls	T-TAS	Healthy individuals
Acute decompensated liver cirrhosis	T-TAS	Acute event causing further decompensation and the need for in-patient care
Non-acute decompensated liver círrhosis	T-TAS	Refractory ascites, low grade encephalopathy but manages to stay at home and only come in ofr check-ups.

Primary Outcome Measures

Name	Time	Method
Correlation between systemic inflammation and hemostasis measured by novel assays	uo to 7 years	Correlation between systemic inflammation measured by cytokines, NETs and ECV and hemostasis measured by novel assays as in outcome 1
Differences in laboratory values between groupstests	up to 5 years	Laboratory values of novel hemostasis tests TTAS, Quantra and OHP correlated to Rotem, TG and conventional coagulation assays. All tests have differnet values.

Secondary Outcome Measures

Name	Time	Method
Number of participant going to transplant	Up to 7 years	Number of patients getting a transplant, acute, subacute or according to waiting list
Number of participant with bleeding	Up to 7 years	Bleeding defined according to ISTH
Number of participants that die	Up to 7 years
Number of participants with Thrombosis	Up to 7 years	Splanchnic or non-splanchnic thrombosis

Trial Locations

Locations (1)

Karolinska University Hospital; 🇸🇪 Stockholm, Huddinge, Sweden