Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-02-21 @ 1:34 AM
Study NCT ID:
NCT04111120
Status:
UNKNOWN
Last Update Posted:
2021-09-28
First Post:
2019-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Heparin Like Effect in Acute Variceal Bleeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'plasma samples will be stored for coagulation factor assays'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-26', 'studyFirstSubmitDate': '2019-09-25', 'studyFirstSubmitQcDate': '2019-09-28', 'lastUpdatePostDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Generation of Endogenous Heparinoids', 'timeFrame': '7 days', 'description': 'Change in SONOCLOT values- global and heparinase treated'}, {'measure': 'Change in plasma levels of Specific Coagulation Factors -VIII, X, XIII, TPA and PAI', 'timeFrame': '7 days', 'description': 'Specific factor assessment'}], 'secondaryOutcomes': [{'measure': 'Correlation of sonoclot parameters- ACT, PF and Peak amplitude in predicting blood product utilization', 'timeFrame': '7 Days', 'description': 'blood transfusion requirements'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['thromboelastography', 'variceal bleeding'], 'conditions': ['Coagulation Disorder', 'Cirrhosis, Liver', 'Variceal Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '35984611', 'type': 'DERIVED', 'citation': 'Premkumar M, Mehtani R, Kulkarni AV, Duseja AK, De A, Taneja S, Singh V, Verma N, Ahluwalia J, Kajal K, Divyaveer S, Roy A, Gandotra A, Kalson N, Kekan K, Kaur H, Kaur H. Association of Heparin-Like Effect, Factor VII/XIII Deficiency and Fibrinolysis with Rebleeding Risk in Cirrhosis with Acute Variceal Bleeding. Dig Dis Sci. 2023 Feb;68(2):497-513. doi: 10.1007/s10620-022-07656-9. Epub 2022 Aug 19.'}]}, 'descriptionModule': {'briefSummary': 'This study attempts to clarify the pathophysiology of haemostasis in relation to the evidence of sepsis in liver disease, and compares the accuracy of various available laboratory tests in assessment of these patients. Further research is needed for proper understanding of the influence of sepsis on coagulation disorders in acute variceal bleeding in cirrhosis, to correctly identify the type and optimal quantity of blood product requirement in at risk patients.\n\nThromboelastography (TEG) /Sonoclot has been proposed as a superior tool to rapidly diagnose and help guide resuscitation with blood products. Secondly, the study of derangement in coagulopathy after the onset of sepsis is of paramount importance because of increased mortality after the onset of sepsis. In the present study, patients with cirrhosis who present with acute variceal bleeding, will be included in the study cohort, and will undergo a baseline diagnostic workup as described. They will be followed for development of any signs of infection after hospitalization. Then the effect of sepsis on their coagulation and thrombin generation response swill be assessed. Thus the effect of sepsis on the progression and outcome of coagulopathy in patients with acute variceal bleeding will be studied.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cirrhosis with acute variceal bleeding', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-65 years\n* Cirrhosis with acute variceal bleeding.\n\nExclusion Criteria:\n\n* Patients with evidence of sepsis at presentation.\n* Current therapy: Recent blood or blood component transfusion in the last 2 weeks.\n* HIV positive/ AIDS patients\n* Patients requiring antiplatelet therapy,\n* Renal insufficiency requiring dialysis\n* Active malignancy within the last 5 years\n* Patient with other neurological disease and metabolic disorders, unbalanced heart failure and/or respiratory failure or end-stage renal disease\n* Administration of anticoagulants, antifibrinolytics,\n* Not willing to participate in the study'}, 'identificationModule': {'nctId': 'NCT04111120', 'briefTitle': 'Heparin Like Effect in Acute Variceal Bleeding', 'organization': {'class': 'OTHER', 'fullName': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}, 'officialTitle': 'Assessment of Coagulation Profile and Role of Endogenous Heparinoids in SIRS and Sepsis in Acute Variceal Bleeding in Cirrhosis', 'orgStudyIdInfo': {'id': 'INT/IEC/2019/001615'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cirrhosis with variceal bleeding', 'description': 'Coagulation factor assays and heparinase treated SONOCLOT at Days 0,3, and 7', 'interventionNames': ['Diagnostic Test: SONOCLOT, coagulation factor assays for VIII/X, XIII, TPA/ PAI']}, {'label': 'Cirrhosis without Bleeding', 'description': 'Control group of 25 subjects', 'interventionNames': ['Diagnostic Test: SONOCLOT, coagulation factor assays for VIII/X, XIII, TPA/ PAI']}], 'interventions': [{'name': 'SONOCLOT, coagulation factor assays for VIII/X, XIII, TPA/ PAI', 'type': 'DIAGNOSTIC_TEST', 'description': 'Coagulation assessment using heparinase treated SONOCLOT', 'armGroupLabels': ['Cirrhosis with variceal bleeding', 'Cirrhosis without Bleeding']}]}, 'contactsLocationsModule': {'locations': [{'zip': '160012', 'city': 'Chandigarh', 'state': 'Choose Any State/Province', 'status': 'RECRUITING', 'country': 'India', 'contacts': [{'name': 'Madhumita Premkumar', 'role': 'CONTACT'}], 'facility': 'Postgraduate Institute of Medical Education and Research', 'geoPoint': {'lat': 30.73629, 'lon': 76.7884}}], 'centralContacts': [{'name': 'Madhumita Premkumar, MD DM', 'role': 'CONTACT', 'email': 'drmadhumitap@gmail.com', 'phone': '01722756344'}], 'overallOfficials': [{'name': 'RK Dhiman, MD DM', 'role': 'STUDY_CHAIR', 'affiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Post Graduate Institute of Medical Education and Research, Chandigarh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Department of Hepatology', 'investigatorFullName': 'Madhumita Premkumar', 'investigatorAffiliation': 'Post Graduate Institute of Medical Education and Research, Chandigarh'}}}}