Ignite Creation Date:
2025-12-24 @ 7:09 PM
Ignite Modification Date:
2026-02-23 @ 4:31 AM
Study NCT ID:
NCT02457403
Status:
COMPLETED
Last Update Posted:
2021-01-22
First Post:
2015-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Blood Product Use and Bleeding Events During and After Endoscopic or Neurosurgical Procedures in Patients With Cirrhosis and Coagulopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'james.hanje@osumc.edu', 'phone': '614 293 6255', 'title': 'A James Hanje', 'organization': 'The Ohio State University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '1 year', 'description': 'Standard definition from clinicaltrials.gov', 'eventGroups': [{'id': 'EG000', 'title': 'ROTEM', 'description': "Assess coagulopathy with ROTEM device compared to conventional laboratory tests. ROTEM will be used on all patients, however, determination of blood products used will be based on patient's randomization group.", 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Conventional', 'description': "Assess coagulopathy with conventional laboratory tests (PT/INR, Hemoglobin, Platelet count). Conventional laboratory tests will be obtained on all subjects, however, determination of blood products used will be based on patient's randomization group.", 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Intra-operative Blood Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ROTEM', 'description': 'Assess coagulopathy with ROTEM device compared to conventional laboratory tests. The ROTEM machine produces values for each of the following: A10-EX, A10-FIB, CT-EX, CT-FIB, and CT-HEP. An algorithm guided the investigator on how to proceed with treatment, whether it be to transfuse 1 unit of platelets \\& 1 unit of cryo, transfuse 1 unit of cryo, transfuse 1 unit of platelets, transfuse 2 units of platelets, transfuse 2 units fresh frozen plasma (FFP), and whether or not to stop heparin.'}, {'id': 'OG001', 'title': 'Conventional', 'description': 'Assess coagulopathy with conventional laboratory tests (PT/INR, Hemoglobin, Platelet count, fibrinogen). Based on these lab results, the investigator followed an algorithm and proceeded by either ordering a transfusion of 2 units fresh frozen plasma (FFP), transfusion of 1 unit of platelets, or a transfusion of 2 units of platelets. And if the Fibrinogen came back at \\< 100 mg/dL, 1 unit of cryoprecipitate was also transfused.'}], 'classes': [{'categories': [{'measurements': [{'value': '2000', 'groupId': 'OG000', 'lowerLimit': '1500', 'upperLimit': '3375'}, {'value': '3000', 'groupId': 'OG001', 'lowerLimit': '2000', 'upperLimit': '7750'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Patients will be evaluated for the duration of their transfusion (no greater than 24 hour span).', 'description': 'Total amount of pre-procedure blood products transfused in patients undergoing endoscopy and neurosurgical procedures.', 'unitOfMeasure': 'milliliters', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Bleeding Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ROTEM', 'description': "Assess coagulopathy with ROTEM device compared to conventional laboratory tests. ROTEM will be used on all patients, however, determination of blood products used will be based on patient's randomization group."}, {'id': 'OG001', 'title': 'Conventional', 'description': "Assess coagulopathy with conventional laboratory tests (PT/INR, Hemoglobin, Platelet count). Conventional laboratory tests will be obtained on all subjects, however, determination of blood products used will be based on patient's randomization group."}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Patients will be assessed for bleeding events from time of consent in the hospital to the time of discharge from the hospitalization (up to a maximum of 6 months).', 'description': "Duration of hospitalization is patient dependent, and is not affected by study interventions. Bleeding events (such as post-procedure bleeding, signs/symptoms of bleeding, or active hemorrhage) will be evaluated by chart review for the duration of each subject's hospitalization (up to a maximum of 6 months).", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ROTEM', 'description': "Assess coagulopathy with ROTEM device compared to conventional laboratory tests. ROTEM will be used on all patients, however, determination of blood products used will be based on patient's randomization group."}, {'id': 'FG001', 'title': 'Conventional', 'description': "Assess coagulopathy with conventional laboratory tests (PT/INR, Hemoglobin, Platelet count). Conventional laboratory tests will be obtained on all subjects, however, determination of blood products used will be based on patient's randomization group."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '34 participants', 'groupId': 'FG000', 'numSubjects': '34'}, {'comment': '34 historic controls', 'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'This is a prospective, single center, randomized clinical trial. 34 controls had transfusions guided by conventional labs and 34 participants had transfusions guided by ROTEM during orthotopic liver transplantation.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ROTEM', 'description': 'Assess coagulopathy with ROTEM device compared to conventional laboratory tests. The ROTEM machine produces values for each of the following: A10-EX, A10-FIB, CT-EX, CT-FIB, and CT-HEP. An algorithm guided the investigator on how to proceed with treatment, whether it be to transfuse 1 unit of platelets \\& 1 unit of cryo, transfuse 1 unit of cryo, transfuse 1 unit of platelets, transfuse 2 units of platelets, transfuse 2 units fresh frozen plasma (FFP), and whether or not to stop heparin.'}, {'id': 'BG001', 'title': 'Conventional', 'description': 'Assess coagulopathy with conventional laboratory tests (PT/INR, Hemoglobin, Platelet count, fibrinogen). Based on these lab results, the investigator followed an algorithm and proceeded by either ordering a transfusion of 2 units fresh frozen plasma (FFP), transfusion of 1 unit of platelets, or a transfusion of 2 units of platelets. And if the Fibrinogen came back at \\< 100 mg/dL, 1 unit of cryoprecipitate was also transfused.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'title': 'Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity : White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}, {'title': 'Race/Ethnicity : Non-white', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Classified as "white/non-white."', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Indication for OLT', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Model for End-Stage Liver Disease Scale (MELD) score', 'classes': [{'title': 'ROTEM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25', 'spread': '8.37', 'groupId': 'BG000'}, {'value': '25', 'spread': '8.37', 'groupId': 'BG002'}]}]}, {'title': 'Conventional', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '22', 'spread': '7.70', 'groupId': 'BG001'}, {'value': '22', 'spread': '7.70', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'MELD score is a scale from 6-40, with a higher score indicating a worse outcome.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Raw data was not available so this was the most efficient way to fulfill the "total" column, and there were only 34 participants in each arm.'}, {'title': 'Presence of hepatocellular carcinoma', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Presence of portal vein thrombosis', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Presence of hypercoaguable state', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-10', 'size': 70576, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-03-10T16:20', 'hasProtocol': False}, {'date': '2017-01-09', 'size': 220669, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-03-10T16:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-31', 'studyFirstSubmitDate': '2015-05-06', 'resultsFirstSubmitDate': '2020-03-12', 'studyFirstSubmitQcDate': '2015-05-26', 'lastUpdatePostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-12-31', 'studyFirstPostDateStruct': {'date': '2015-05-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intra-operative Blood Loss', 'timeFrame': 'Patients will be evaluated for the duration of their transfusion (no greater than 24 hour span).', 'description': 'Total amount of pre-procedure blood products transfused in patients undergoing endoscopy and neurosurgical procedures.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Bleeding Events', 'timeFrame': 'Patients will be assessed for bleeding events from time of consent in the hospital to the time of discharge from the hospitalization (up to a maximum of 6 months).', 'description': "Duration of hospitalization is patient dependent, and is not affected by study interventions. Bleeding events (such as post-procedure bleeding, signs/symptoms of bleeding, or active hemorrhage) will be evaluated by chart review for the duration of each subject's hospitalization (up to a maximum of 6 months)."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Cirrhosis', 'Coagulopathy']}, 'descriptionModule': {'briefSummary': 'A prospective, randomized clinical trial comparing blood product use and bleeding events during and after endoscopic or neurosurgical procedures in patients with cirrhosis and coagulopathy: Rotational Thromboelastometry (ROTEM) vs. conventional therapy (SCARLET).', 'detailedDescription': 'Orthotopic liver transplantation (OLT) can be associated with significant bleeding requiring multiple blood product transfusions, especially in patients with severe liver dysfunction. Rotational thromboelastometry (ROTEM) is a point-of-care device that has been used successfully to monitor coagulation on whole blood samples during OLT. Whether it allows blood loss and transfusion to be reduced during OLT remains controversial. ROTEM or conventional coagulation tests were used in this study to guide transfusion of platelets, cryoprecipitate, and fresh frozen plasma (FFP) during OLT. Patient characteristics as well as pre- and post- transplant laboratory data were collected. Intra-operative blood loss, type and amount of blood products transfused, and cost were compared between the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 and older, admitted to the hospital\n* Patients who have clinically documented cirrhosis\n* Patients who are coagulopathic (INR \\> 1.5 and/or platelets \\< 50,000)\n* Patients undergoing an endoscopic procedure or neurosurgical procedure\n\nExclusion Criteria:\n\n* Patients must not be pregnant\n* Patients must not be taking any anticoagulant or antiplatelet medication (with the exception of ASA 81 mg or heparin for DVT prophylaxis)\n* Patients must not have an active infection (per PI discretion)\n* Patients must not have any known hemostatic disorder'}, 'identificationModule': {'nctId': 'NCT02457403', 'acronym': 'SCARLET', 'briefTitle': 'Comparison of Blood Product Use and Bleeding Events During and After Endoscopic or Neurosurgical Procedures in Patients With Cirrhosis and Coagulopathy', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'A Prospective, Randomized Clinical Trial Comparing Blood Product Use and Bleeding Events During and After Endoscopic or Neurosurgical Procedures in Patients With Cirrhosis and Coagulopathy: Rotational Thromboelastography (ROTEM) Versus Conventional Therapy', 'orgStudyIdInfo': {'id': '2014H0487'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ROTEM', 'description': 'Transfusion guided by ROTEM during OLT', 'interventionNames': ['Device: ROTEM', 'Other: Conventional Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional', 'description': 'Transfusion guided by conventional labs', 'interventionNames': ['Device: ROTEM', 'Other: Conventional Therapy']}], 'interventions': [{'name': 'ROTEM', 'type': 'DEVICE', 'description': "Assess coagulopathy with ROTEM device compared to conventional laboratory tests. ROTEM will be used on all patients, however, determination of blood products used will be based on patient's randomization group.", 'armGroupLabels': ['Conventional', 'ROTEM']}, {'name': 'Conventional Therapy', 'type': 'OTHER', 'description': "Assess coagulopathy with conventional laboratory tests (PT/INR, Hemoglobin, Platelet count). Conventional laboratory tests will be obtained on all subjects, however, determination of blood products used will be based on patient's randomization group.", 'armGroupLabels': ['Conventional', 'ROTEM']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Adam J Hanje, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor-Clinical'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'James Hanje', 'investigatorAffiliation': 'Ohio State University'}}}}