Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2026-01-11 @ 11:43 AM
Study NCT ID:
NCT02689232
Status:
COMPLETED
Last Update Posted:
2018-11-28
First Post:
2016-02-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TEG (Thromboelastography) Based Versus Conventional Coagulation Parameters Based Correction of Coagulopathy in Non Variceal Bleed.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-26', 'studyFirstSubmitDate': '2016-02-13', 'studyFirstSubmitQcDate': '2016-02-18', 'lastUpdatePostDateStruct': {'date': '2018-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of FFP (Fresh Frozen Plasma) transfusion in both groups', 'timeFrame': '42 days'}], 'secondaryOutcomes': [{'measure': 'Number of patients with bleed in both groups', 'timeFrame': '5 days'}, {'measure': 'Incidence of TRALI (Transfusion associated lung injury) and TACO ( Transfusion associated circulatory overload) in both the groups.', 'timeFrame': '42 days'}, {'measure': 'Early mortality ( <6 weeks) and late mortality (> 6 weeks) in both the groups.', 'timeFrame': '42 days'}, {'measure': 'Amount of blood products (Platelet and cryo and Red Blood Cells)transfused in both the groups.', 'timeFrame': '42 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Non Variceal Bleed']}, 'referencesModule': {'references': [{'pmid': '31148204', 'type': 'DERIVED', 'citation': 'Kumar M, Ahmad J, Maiwall R, Choudhury A, Bajpai M, Mitra LG, Saluja V, Mohan Agarwal P, Bihari C, Shasthry SM, Jindal A, Bhardwaj A, Kumar G, Sarin SK. Thromboelastography-Guided Blood Component Use in Patients With Cirrhosis With Nonvariceal Bleeding: A Randomized Controlled Trial. Hepatology. 2020 Jan;71(1):235-246. doi: 10.1002/hep.30794. Epub 2019 Aug 27.'}]}, 'descriptionModule': {'briefSummary': 'All patients with non variceal bleed who are admitted under the Department of Hepatology at Institute of Liver and Biliary Sciences, who meet the inclusion criteria and who provide informed consent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age more than 18\n* All patient with Non Variceal bleed (INR\\>1.8 and platelets\\<50000)\n* Hist logical or imaging proven liver cirrhosis.\n\nExclusion Criteria:\n\n1. Variceal Bleed,\n2. Pregnancy.,\n3. Patients on anticoagulation\n4. Patients who refused to participate in the study\n5. Post EVL ulcer bleed'}, 'identificationModule': {'nctId': 'NCT02689232', 'briefTitle': 'TEG (Thromboelastography) Based Versus Conventional Coagulation Parameters Based Correction of Coagulopathy in Non Variceal Bleed.', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Liver and Biliary Sciences, India'}, 'officialTitle': 'TEG (Thromboelastography) Based Versus Conventional Coagulation Parameters Based Correction of Coagulopathy in Non Variceal Bleed: An Open Label Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'ILBS-Variceal Bleed-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thromboelastography (TEG) level', 'interventionNames': ['Biological: Fresh Frozen Plasma', 'Biological: Platelets Concentrate', 'Biological: Cryo Precitipitate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Coagulation Profile', 'interventionNames': ['Biological: Fresh Frozen Plasma', 'Biological: Platelets Concentrate', 'Biological: Cryo Precitipitate']}], 'interventions': [{'name': 'Fresh Frozen Plasma', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Coagulation Profile', 'Thromboelastography (TEG) level']}, {'name': 'Platelets Concentrate', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Coagulation Profile', 'Thromboelastography (TEG) level']}, {'name': 'Cryo Precitipitate', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Coagulation Profile', 'Thromboelastography (TEG) level']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110070', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'Institute of Liver & Biliary Sciences', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '110070', 'city': 'New Delhi', 'state': 'National Capital Territory of Delhi', 'country': 'India', 'facility': 'Institute of liver and Biliary Sciences', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}], 'overallOfficials': [{'name': 'Dr Juned Ahmad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Liver and Biliary Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Liver and Biliary Sciences, India', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}