Karolinska University Hospital
Stockholm, Huddinge, 14186, Sweden
Location status: Recruiting
Recruiting
NCT Number: NCT06212635
Hemostasis in Liver Cirrhosis and Hepatocellular Cancer
Evaluating hemostasis in decompensated liver cirrhosis with novel hemostatic assays.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
T-TAS
Diagnostic TestBlood test, laboratory assays
Other names: Quantra, OHP
Primary outcomes
-
Differences in laboratory values between groupstests
Time frame: 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.
-
Correlation between systemic inflammation and hemostasis measured by novel assays
Time frame: uo to 7 years
Correlation between systemic inflammation measured by cytokines, NETs and ECV and hemostasis measured by novel assays as in outcome 1
Secondary outcomes
-
Number of participant with bleeding
Time frame: Up to 7 years
Bleeding defined according to ISTH
-
Number of participants with Thrombosis
Time frame: Up to 7 years
Splanchnic or non-splanchnic thrombosis
-
Number of participants that die
Time frame: Up to 7 years
-
Number of participant going to transplant
Time frame: Up to 7 years
Number of patients getting a transplant, acute, subacute or according to waiting list
Study contacts
Contact information is provided by the study sponsor or research team.
Maria Magnusson, MD, PhD
CONTACT
Sanna Norén, MD, PhDstudent
CONTACT
Sponsors and collaborators
Lead sponsor
Region Stockholm
Other Gov
Collaborators
- Sahlgrenska University Hospital
Registry information
Official study title
Novel Biomarkers for Evaluation of Hemostasis and Inflammation in Liver Cirrhosis
Acronym: HELICS
Important dates
- Study start
- 2022
- Primary completion
- 2026
- Study completion
- 2028
- First posted
- Jan 19, 2024
- Registry last updated
- Jan 19, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.