Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-31 @ 1:33 PM
Study NCT ID:
NCT05667805
Status:
RECRUITING
Last Update Posted:
2025-01-14
First Post:
2022-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Coagulation in Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005164', 'term': 'Factor IX'}, {'id': 'C025667', 'term': 'prothrombin complex concentrates'}], 'ancestors': [{'id': 'D004792', 'term': 'Enzyme Precursors'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011498', 'term': 'Protein Precursors'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'interventional radiologists'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-10', 'studyFirstSubmitDate': '2022-12-16', 'studyFirstSubmitQcDate': '2022-12-27', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major Bleeding', 'timeFrame': '3 days', 'description': 'bleeding complication within 3 days after the intervention'}], 'secondaryOutcomes': [{'measure': 'bleeding complication', 'timeFrame': '28 days', 'description': 'bleeding complication within 28 days after the intervention'}, {'measure': 'thromboembolic events', 'timeFrame': '28 days'}, {'measure': 'transfusion related complications', 'timeFrame': '28 days'}, {'measure': '28 day overall mortality', 'timeFrame': '28 days'}, {'measure': '28 day bleeding related mortality', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patient Blood Management', 'Platelet Concentrates', 'Transfusion', 'Coagulation'], 'conditions': ['Liver Cirrhosis']}, 'descriptionModule': {'briefSummary': 'Out of fear of bleeding, liver cirrhosis patients are often treated prophylactically with blood and coagulation products before minor interventions. The COUCH study will examine whether these patients benefit from a restrictive administration of coagulation products.', 'detailedDescription': 'Patients with cirrhosis commonly have deranged coagulation parameters, in particular thrombocytopenia and/or an increased INR. However, these laboratory findings do not necessarily correlate with an increased tendency of bleeding. In fact, the reduced synthesis of both pro- and anticoagulant factors often equates to a new equilibrium in the coagulation system. Nevertheless, out of fear of bleeding, liver cirrhosis patients with deviated laboratory coagulation parameters are often aggressively treated with coagulation products (such as platelet concentrates and prothrombin complex concentrate (PCC)) before minor interventions and punctures. Since these products can also have procoagulant side effects, we will investigate whether patients with liver cirrhosis without a history of bleeding or clinical bleeding signs benefit from a restrictive substitution regime. The study will be carried out monocentrically at the General Hospital of Vienna, and will include 400 patients divided into two groups (liberal vs. restrictive substitution of thrombocytes and/or PCC) over an est. period of 4 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients at the University Hospital of Vienna with diagnosed liver cirrhosis and deranged coagulation parameters (INR \\>1,5 AND/ OR platelet count \\<50 G/L) who are scheduled for one of the following elective invasive interventions of the liver\n\n* Biopsy or puncture\n* Microwave ablation (MWA) or radiofrequency ablation (RFA)\n* Transjugular intrahepatic portosystemic shunt (TIPS)\n* Percutaneous transhepatic cholangiography drain (PTCD)\n\nExclusion Criteria:\n\n* Missing informed consent or inability to consent\n* Age \\< 18 years\n* Pregnancy or breastfeeding\n* Manifest ascites\n* Chronic kidney injury stage G4 or G5, KDIGO\n* Uninterrupted anticoagulant therapy, except for acetylsalicylic acid (ASA)\n* History of bleeding or clinical signs of a hemorrhagic diathesis in the physical examination (e.g., petechia, ecchymosis, mucosal bleeding, hemorrhagic diathesis within the family, menorrhagia, prolonged bleeding after surgery)'}, 'identificationModule': {'nctId': 'NCT05667805', 'acronym': 'COUCH', 'briefTitle': 'Coagulation in Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Coagulation in Cirrhosis', 'orgStudyIdInfo': {'id': '1144/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Liberal substitution of human prothrombin complex and/or platelet concentrates', 'description': 'If INR \\< 1,5: 10 I.E. human prothrombin complex/kg bodyweigt/0,5 INR AND/OR If platelets \\< 50 G/l: ((50 G/l - measured thrombocyte concentration G/l) x total blood volume) platelet concentrate', 'interventionNames': ['Drug: Platelet Concentrate', 'Drug: Prothrombin Complex Concentrate']}, {'type': 'EXPERIMENTAL', 'label': 'Restrictive substitution of human prothrombin complex and/or thrombocytes', 'description': 'No substitution of blood products described in the Active Comparator group.', 'interventionNames': ['Other: Restricitve Use']}], 'interventions': [{'name': 'Platelet Concentrate', 'type': 'DRUG', 'description': 'Liberal use (standard treatment)', 'armGroupLabels': ['Liberal substitution of human prothrombin complex and/or platelet concentrates']}, {'name': 'Prothrombin Complex Concentrate', 'type': 'DRUG', 'otherNames': ['PPSB'], 'description': 'Liberal use (standard treatment)', 'armGroupLabels': ['Liberal substitution of human prothrombin complex and/or platelet concentrates']}, {'name': 'Restricitve Use', 'type': 'OTHER', 'description': 'Restrictive use of human prothrombin complex and platelet concentrates. No prophylactic substitution.', 'armGroupLabels': ['Restrictive substitution of human prothrombin complex and/or thrombocytes']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'David M Baron, MD', 'role': 'CONTACT'}, {'name': 'David M Baron, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'General Hospital of the Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Armin Langauer, MD', 'role': 'CONTACT', 'email': 'armin.langauer@meduniwien.ac.at', 'phone': '+43 1 40400 41000'}, {'name': 'Kristina Nieding, MD', 'role': 'CONTACT', 'email': 'kristina.nieding@meduniwien.ac.at', 'phone': '+43 1 40400 41000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'David M Baron, MD, PhD', 'investigatorAffiliation': 'Medical University of Vienna'}}}}