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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Region StockholmThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Biomarkers for Evaluation of Hemostasis and Inflammation in Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT06212635
- Acronym / sponsor ID
- HELICS / 2020-00316200610
- Conditions
- Hemostasis in Decompensated Liver Cirrhosis, Inflammation in Decompensated Liver Cirrhosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Collaborators
- Sahlgrenska University Hospital
- Study start
- 2 Dec 2022 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 19 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-acute decompensated liver círrhosis | – | Diagnostic Test: T-TASRefractory ascites, low grade encephalopathy but manages to stay at home and only come in ofr check-ups. |
| Acute decompensated liver cirrhosis | – | Diagnostic Test: T-TASAcute event causing further decompensation and the need for in-patient care |
| Acute on chronic liver failure | – | Diagnostic Test: T-TASACLF 1-3 accordic to criterias established through the Cannonic study. |
| Controls | – | Diagnostic Test: T-TASHealthy individuals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 40 patients each with NAD, AD and ACF and 30 healthy volunteers.
Key inclusion criteria (3 listed)
- Patients with decompensated liver cirrhosis
- 18 years or older.
- Healthy individuals 18 years or older will serve as controls.
Key exclusion criteria (6 listed)
- • Extrahepatic malignancy or recurrence of such within the last year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-TASAlso: Quantra, OHPBlood test, laboratory assays | Diagnostic test | Acute decompensated liver cirrhosis, Acute on chronic liver failure, Controls, Non-acute decompensated liver círrhosis |
Primary outcome
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
4 secondary outcomes
Number of participant with bleeding
Time frame: Up to 7 years
Number of participants with Thrombosis
Time frame: Up to 7 years
Number of participants that die
Time frame: Up to 7 years
Number of participant going to transplant
Time frame: Up to 7 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2024.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maria Magnusson, MD, PhD contact
Maria Magnusson, MD, PhD principal investigator
Region Stockholm, Karolinska Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemostasis in Decompensated Liver Cirrhosis and Inflammation in Decompensated Liver Cirrhosis, run by Region Stockholm at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sanna Norén, MD, PhDstudent (+46703131799, sanna.noren@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in laboratory values between groupstests (time frame: up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2024.