Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-25 @ 8:07 PM
Study NCT ID:
NCT06212635
Status:
RECRUITING
Last Update Posted:
2024-01-19
First Post:
2023-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hemostasis in Liver Cirrhosis and Hepatocellular Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Hemostasis assays, inflammation assays, DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2028-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-08', 'studyFirstSubmitDate': '2023-02-22', 'studyFirstSubmitQcDate': '2024-01-08', 'lastUpdatePostDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in laboratory values between groupstests', 'timeFrame': 'up to 5 years', 'description': 'Laboratory values of novel hemostasis tests TTAS, Quantra and OHP correlated to Rotem, TG and conventional coagulation assays. All tests have differnet values.'}, {'measure': 'Correlation between systemic inflammation and hemostasis measured by novel assays', 'timeFrame': 'uo to 7 years', 'description': 'Correlation between systemic inflammation measured by cytokines, NETs and ECV and hemostasis measured by novel assays as in outcome 1'}], 'secondaryOutcomes': [{'measure': 'Number of participant with bleeding', 'timeFrame': 'Up to 7 years', 'description': 'Bleeding defined according to ISTH'}, {'measure': 'Number of participants with Thrombosis', 'timeFrame': 'Up to 7 years', 'description': 'Splanchnic or non-splanchnic thrombosis'}, {'measure': 'Number of participants that die', 'timeFrame': 'Up to 7 years'}, {'measure': 'Number of participant going to transplant', 'timeFrame': 'Up to 7 years', 'description': 'Number of patients getting a transplant, acute, subacute or according to waiting list'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Hemostasis in Decompensated Liver Cirrhosis', 'Inflammation in Decompensated Liver Cirrhosis']}, 'descriptionModule': {'briefSummary': 'Evaluating hemostasis in decompensated liver cirrhosis with novel hemostatic assays.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '40 patients each with NAD, AD and ACF and 30 healthy volunteers.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with decompensated liver cirrhosis\n* 18 years or older.\n* Healthy individuals 18 years or older will serve as controls.\n\nExclusion Criteria:\n\n* • Extrahepatic malignancy or recurrence of such within the last year.\n\n * Diagnosis of non-cirrhotic coagulopathy, coagulation disorder or thrombophilia prior to inclusion.\n * Diagnosis of hematological disease such as hematologic malignancies, non-cirrhotic thrombocytopenia or thrombocytosis, Polycytemia Vera, hemoglobinopathies\n * Previous liver transplantation.\n * Transfusions the last 7 days.\n * 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.'}, 'identificationModule': {'nctId': 'NCT06212635', 'acronym': 'HELICS', 'briefTitle': 'Hemostasis in Liver Cirrhosis and Hepatocellular Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Region Stockholm'}, 'officialTitle': 'Novel Biomarkers for Evaluation of Hemostasis and Inflammation in Liver Cirrhosis', 'orgStudyIdInfo': {'id': '2020-00316200610'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-acute decompensated liver círrhosis', 'description': 'Refractory ascites, low grade encephalopathy but manages to stay at home and only come in ofr check-ups.', 'interventionNames': ['Diagnostic Test: T-TAS']}, {'label': 'Acute decompensated liver cirrhosis', 'description': 'Acute event causing further decompensation and the need for in-patient care', 'interventionNames': ['Diagnostic Test: T-TAS']}, {'label': 'Acute on chronic liver failure', 'description': 'ACLF 1-3 accordic to criterias established through the Cannonic study.', 'interventionNames': ['Diagnostic Test: T-TAS']}, {'label': 'Controls', 'description': 'Healthy individuals', 'interventionNames': ['Diagnostic Test: T-TAS']}], 'interventions': [{'name': 'T-TAS', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Quantra', 'OHP'], 'description': 'Blood test, laboratory assays', 'armGroupLabels': ['Acute decompensated liver cirrhosis', 'Acute on chronic liver failure', 'Controls', 'Non-acute decompensated liver círrhosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14186', 'city': 'Stockholm', 'state': 'Huddinge', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Sanna Norén, MD, PhDstudent', 'role': 'CONTACT', 'email': 'sanna.noren@regionstockholm.se'}], 'facility': 'Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'centralContacts': [{'name': 'Sanna Norén, MD, PhDstudent', 'role': 'CONTACT', 'email': 'sanna.noren@regionstockholm.se', 'phone': '+46703131799'}, {'name': 'Maria Magnusson, MD, PhD', 'role': 'CONTACT', 'email': 'maria.s.magnusson@regionstockholm.se'}], 'overallOfficials': [{'name': 'Maria Magnusson, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Region Stockholm, Karolinska Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Stockholm', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}