Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2026-03-06 @ 9:43 PM
Study NCT ID:
NCT04762550
Status:
UNKNOWN
Last Update Posted:
2021-05-03
First Post:
2021-02-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thrombin Generation in Liver Transplant Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001778', 'term': 'Blood Coagulation Disorders'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Whole blood and plasma specimens in citrated tubes'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-29', 'studyFirstSubmitDate': '2021-02-02', 'studyFirstSubmitQcDate': '2021-02-16', 'lastUpdatePostDateStruct': {'date': '2021-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Transfusion Outcomes - Red Blood Cells', 'timeFrame': 'From intra-operatively to within 12 hours post-operatively', 'description': 'The total number of red blood cells transfused'}, {'measure': 'Transfusion Outcomes - Platelets', 'timeFrame': 'From intra-operatively to within 12 hours post-operatively', 'description': 'The total number of platelet units transfused'}, {'measure': 'Transfusion Outcomes - Frozen Plasma', 'timeFrame': 'From intra-operatively to within 12 hours post-operatively', 'description': 'The total number of frozen plasma units transfused'}, {'measure': 'Transfusion Outcomes - Prothrombin Complex Concentrate', 'timeFrame': 'From intra-operatively to within 12 hours post-operatively', 'description': 'The total number of units transfused'}, {'measure': 'Transfusion Outcomes - Fibrinogen Concentrate', 'timeFrame': 'From intra-operatively to within 12 hours post-operatively', 'description': 'The total number of grams of fibrinogen transfused'}, {'measure': 'Bleeding Outcomes - Delayed Abdominal Closure', 'timeFrame': 'From intra-operatively to within 12 hours post-operatively', 'description': 'Clinical bleeding outcome such as delayed abdominal'}, {'measure': 'Bleeding Outcomes - Return to the Operating Room for Re-Exploration', 'timeFrame': 'From intra-operatively to within 12 hours post-operatively', 'description': 'Clinical bleeding outcome such as return to the operating room for re-exploration or evacuation of hematoma'}], 'primaryOutcomes': [{'measure': 'Thrombin Generation - Endogenous Thrombin Potential (nM*min)', 'timeFrame': 'The pattern of change in thrombin generation will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively', 'description': 'The change in thrombin generation will be measured in patients undergoing liver transplantation, as assessed through the Endogenous Thrombin Potential (nM\\*min)'}, {'measure': 'Thrombin Generation - Lag Time (Seconds)', 'timeFrame': 'The pattern of change in thrombin generation will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively', 'description': 'The change in thrombin generation will be measured in patients undergoing liver transplantation as assessed by the Lag Time (Seconds)'}, {'measure': 'Thrombin Generation - Time to Peak (Seconds)', 'timeFrame': 'The pattern of change in thrombin generation will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively', 'description': 'The change in thrombin generation will be measured in patients undergoing liver transplantation by the Time to Peak (Seconds)'}, {'measure': 'Thrombin Generation - Peak Height (nM)', 'timeFrame': 'The pattern of change in thrombin generation will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively', 'description': 'The change in thrombin generation will be measured in patients undergoing liver transplantation by the Peak Height (nM)'}], 'secondaryOutcomes': [{'measure': 'Conventional Hemostatic Tests - Platelet Count', 'timeFrame': 'The pattern of change will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively', 'description': 'The platelet count from the complete blood count in x10\\^9/L'}, {'measure': 'Conventional Hemostatic Tests - INR', 'timeFrame': 'The pattern of change will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively', 'description': 'The international normalized ratio (INR) in seconds'}, {'measure': 'Conventional Hemostatic Tests - aPTT', 'timeFrame': 'The pattern of change will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively', 'description': 'The activated partial thromboplastin time (aPTT) in seconds'}, {'measure': 'Conventional Hemostatic Tests - Fibrinogen Level', 'timeFrame': 'The pattern of change will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively', 'description': 'The Clauss Fibrinogen level in g/L'}, {'measure': 'Viscoelastic Testing', 'timeFrame': 'The pattern of change will be assessed intra-operatively at baseline through to study completion up to 12 hours post-operatively', 'description': 'Rotational thromboelastometry (ROTEM)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Transplantation', 'Thrombin', 'Hemostasis, Surgical', 'Blood Coagulation Disorder Due to Liver Disease', 'Blood Coagulation Disorders']}, 'descriptionModule': {'briefSummary': 'This is a prospective observational study of 100 patients undergoing liver transplantation at a single centre. Thrombin generation and kinetics will be assessed using a novel point-of-care device, and compared to conventional measures of hemostasis as well as viscoelastic tests to pinpoint specific coagulation deficits and identify potential therapeutic targets. The clinical course of patients will be followed for major bleeding and transfusion outcomes.', 'detailedDescription': 'Liver transplantation is the only curative option for end stage liver disease, but is associated with high morbidity and mortality. End stage liver disease is known to be accompanied by dysregulated coagulation, which is further exacerbated in the immediate perioperative period by transplantation, leading to both coagulopathic bleeding and thrombosis. Altered thrombin generation is thought to play a key role in the predisposition of these patients for both severe coagulopathic hemorrhage and life-threatening thromboembolic complications. Despite this, thrombin generation during the immediate transplant period in patients with end-stage liver disease is poorly characterized, in part because it is not well reflected by conventional measures of coagulation. This study aims to characterize changes in thrombin generation capacity pre, intra- and post-transplant utilizing a novel point-of-care thrombin generation assay. Other specific aims of the study are to identify risk factors for patients with impaired thrombin generation and will assess the association of impaired thrombin generation with overall clinical bleeding risk. The overarching goal of this work is to develop a point-of-care-testing guided algorithm addressing dysregulated thrombin formation that improves coagulation management without increasing the risk of thromboembolic complications. Ultimately, this line of research will improve the outcomes of liver transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All consenting adults undergoing liver transplantation surgery at Toronto General Hospital', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adult patients (\\> 18 years of age) proceeding to imminent (within 24 hours) liver transplantation surgery at Toronto General Hospital will be offered participation.\n* Patients should have end stage liver disease necessitating transplantation. All etiologies of end stage liver disease will be accepted.\n\nExclusion Criteria:\n\n\\- Patients who are unable to consent to the study or who refuse participation will be excluded.'}, 'identificationModule': {'nctId': 'NCT04762550', 'briefTitle': 'Thrombin Generation in Liver Transplant Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Diagnosis and Management of Impaired Thrombin Generation in Liver Transplant Surgery', 'orgStudyIdInfo': {'id': '20-5414.0'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients undergoing Liver Transplantation', 'description': 'This is a prospective observational study that intends to offer participation to all patients undergoing liver transplantation at Toronto General Hospital. Parameters that will be measured include Thrombin generation, viscoelastic testing utilizing ROTEM, and conventional laboratory testing (INR, aPTT and Fibrinogen level) at five time points: (a) Prior to cross-clamp application; (b) within the first 30 minutes of venous cross clamp removal; (c) after 30 minutes of reperfusion; (d) On arrival in the intensive care unit (ICU) or post-anesthesia recovery unit; and (5) 12 hours post-operatively.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Justyna Bartoszko, MD MSc FRCPC', 'role': 'CONTACT', 'email': 'justyna.bartoszko@uhn.ca', 'phone': '416-340-3567'}], 'facility': 'Toronto General Hospital - University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Justyna Bartoszko, MD MSc FRCPC', 'role': 'CONTACT', 'email': 'justyna.bartoszko@uhn.ca', 'phone': '416-340-4800', 'phoneExt': '3243'}], 'overallOfficials': [{'name': 'Justyna Bartoszko, MD MSc FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Toronto General Hospital - University Health Network'}, {'name': 'Keyvan Karkouti, MD MSc FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Toronto General Hospital - University Health Network'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}