Hemostasis in Decompensated Liver CirrhosisHELICSNCT06212635
Hemostasis in Liver Cirrhosis and Hepatocellular Cancer
An observational study of Hemostasis in Decompensated Liver Cirrhosis and Inflammation in Decompensated Liver Cirrhosis, run by Region Stockholm at 1 site in Sweden.
Trial summary
Evaluating hemostasis in decompensated liver cirrhosis with novel hemostatic assays. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemostasis in Decompensated Liver Cirrhosis, Inflammation in Decompensated Liver Cirrhosis
- What is being tested?
- T-TAS
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- 2 Dec 2022to 1 Dec 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 40 patients each with NAD, AD and ACF and 30 healthy volunteers.
Who may be able to join
- Patients with decompensated liver cirrhosis
- 18 years or older.
- Healthy individuals 18 years or older will serve as controls.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Maria Magnusson, MD, PhD contact
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Stockholm, Huddinge, 14186
Sanna Norén, MD, PhDstudent, sanna.noren@regionstockholm.se
About this study
Official title: Novel Biomarkers for Evaluation of Hemostasis and Inflammation in Liver Cirrhosis
Evaluating hemostasis in decompensated liver cirrhosis with novel hemostatic assays.
Read the 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.
- Conditions
- Hemostasis in Decompensated Liver Cirrhosis, Inflammation in Decompensated Liver Cirrhosis
- Being tested
- T-TAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-TASDiagnostic test
Also called Quantra, OHP
Blood test, laboratory assays
| Study group | Role | What they receive |
|---|---|---|
| Non-acute decompensated liver círrhosis | Refractory ascites, low grade encephalopathy but manages to stay at home and only come in ofr check-ups. Receives: Diagnostic Test: T-TAS | |
| Acute decompensated liver cirrhosis | Acute event causing further decompensation and the need for in-patient care Receives: Diagnostic Test: T-TAS | |
| Acute on chronic liver failure | ACLF 1-3 accordic to criterias established through the Cannonic study. Receives: Diagnostic Test: T-TAS | |
| Controls | Healthy individuals Receives: Diagnostic Test: T-TAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: uo to 7 years
Secondary outcomes (4)
Number of participant with bleeding
Bleeding defined according to ISTH
Measured: Up to 7 years
Number of participants with Thrombosis
Splanchnic or non-splanchnic thrombosis
Measured: Up to 7 years
Number of participants that die
Measured: Up to 7 years
Number of participant going to transplant
Number of patients getting a transplant, acute, subacute or according to waiting list
Measured: Up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study start2 Dec 2022
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemostasis in Decompensated Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Collaborators
- Sahlgrenska University Hospital
- Responsible party
- Sponsor
- Investigators
- Maria Magnusson, MD, PhD, Principal investigator, Region Stockholm, Karolinska Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212635
- Sponsor's protocol ID
- 2020-00316200610
- Acronym
- HELICS
- Status last verified
- Feb 2023
- First submitted
- 22 Feb 2023
- Last updated
- 19 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided