Hemostasis in Liver Cirrhosis and Hepatocellular Cancer (HELICS)

Novel Biomarkers for Evaluation of Hemostasis and Inflammation in Liver Cirrhosis

Evaluating hemostasis in decompensated liver cirrhosis with novel hemostatic assays.

Study Overview

• Status: Recruiting
• Conditions: Hemostasis in Decompensated Liver Cirrhosis; Inflammation in Decompensated Liver Cirrhosis
• Intervention / Treatment: Diagnostic test: T-TAS

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Sanna Norén, MD, PhDstudent; Phone Number: +46703131799; Email: sanna.noren@regionstockholm.se
• Study Contact Backup: Name: Maria Magnusson, MD, PhD; Email: maria.s.magnusson@regionstockholm.se

Study Locations

• Sweden
  • Huddinge
    • Stockholm, Huddinge, Sweden, 14186
      • Recruiting
      • Karolinska University Hospital
      • Contact: Sanna Norén, MD, PhDstudent; Email: sanna.noren@regionstockholm.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

40 patients each with NAD, AD and ACF and 30 healthy volunteers.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non-acute decompensated liver círrhosis; Refractory ascites, low grade encephalopathy but manages to stay at home and only come in ofr check-ups.	Diagnostic test: T-TAS; Blood test, laboratory assays; Other Names: Quantra; OHP
Acute decompensated liver cirrhosis; Acute event causing further decompensation and the need for in-patient care	Diagnostic test: T-TAS; Blood test, laboratory assays; Other Names: Quantra; OHP
Acute on chronic liver failure; ACLF 1-3 accordic to criterias established through the Cannonic study.	Diagnostic test: T-TAS; Blood test, laboratory assays; Other Names: Quantra; OHP
Controls; Healthy individuals	Diagnostic test: T-TAS; Blood test, laboratory assays; Other Names: Quantra; OHP

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Region Stockholm
• Collaborators: Sahlgrenska University Hospital, Sweden
• Investigators: Principal Investigator: Maria Magnusson, MD, PhD, Region Stockholm, Karolinska Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Actual): January 19, 2024

Study Record Updates

• Last Update Posted (Actual): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Inflammation; Liver Cirrhosis
• Other Study ID Numbers: 2020-00316200610

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No