Skip to content

Hemostasis in Liver Cirrhosis and Hepatocellular Cancer

Novel Biomarkers for Evaluation of Hemostasis and Inflammation in Liver Cirrhosis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06212635
Acronym
HELICS
Enrollment
100
Registered
2024-01-19
Start date
2022-12-02
Completion date
2028-12-01
Last updated
2024-01-19

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

Conditions

Hemostasis in Decompensated Liver Cirrhosis, Inflammation in Decompensated Liver Cirrhosis

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.

Interventions

DIAGNOSTIC_TESTT-TAS

Blood test, laboratory assays

Sponsors

Sahlgrenska University Hospital
CollaboratorOTHER
Region Stockholm
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Differences in laboratory values between groupstestsup to 5 yearsLaboratory values of novel hemostasis tests TTAS, Quantra and OHP correlated to Rotem, TG and conventional coagulation assays. All tests have differnet values.
Correlation between systemic inflammation and hemostasis measured by novel assaysuo to 7 yearsCorrelation between systemic inflammation measured by cytokines, NETs and ECV and hemostasis measured by novel assays as in outcome 1

Secondary

MeasureTime frameDescription
Number of participant with bleedingUp to 7 yearsBleeding defined according to ISTH
Number of participants with ThrombosisUp to 7 yearsSplanchnic or non-splanchnic thrombosis
Number of participants that dieUp to 7 years
Number of participant going to transplantUp to 7 yearsNumber of patients getting a transplant, acute, subacute or according to waiting list

Countries

Sweden

Contacts

Primary ContactSanna Norén, MD, PhDstudent
sanna.noren@regionstockholm.se+46703131799
Backup ContactMaria Magnusson, MD, PhD
maria.s.magnusson@regionstockholm.se

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026