Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-30 @ 6:57 AM
Study NCT ID:
NCT01248104
Status:
COMPLETED
Last Update Posted:
2020-10-19
First Post:
2010-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Comparison of Tranexamic to Epsilon Aminocaproic Acid: a Prospective Analysis of Blood Conservation in Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}, {'id': 'D015119', 'term': 'Aminocaproic Acid'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000614', 'term': 'Aminocaproates'}, {'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jgatling@llu.edu', 'phone': '909-558-4475', 'title': 'Dr. Jason Gatling', 'phoneExt': '44475', 'organization': 'Loma Linda University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'length of hospital admission, an average of 5 days', 'description': 'adverse events were recorded via review of electronic medical record', 'eventGroups': [{'id': 'EG000', 'title': 'Tranexamic Acid', 'description': 'Tranexamic Acid: Infusion during cardiac surgery', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Aminocaproic Acid', 'description': 'Aminocaproic Acid: Infusion during cardiac surgery', 'otherNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Transfusion Amounts', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Tranexamic Acid', 'description': 'Tranexamic Acid: Infusion during cardiac surgery'}, {'id': 'OG001', 'title': 'Aminocaproic Acid', 'description': 'Aminocaproic Acid: Infusion during cardiac surgery'}], 'classes': [{'categories': [{'measurements': [{'value': '161', 'spread': '274', 'groupId': 'OG000'}, {'value': '116', 'spread': '296', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.35', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The primary outcome measure showed that there was no difference in PRBC transfusion frequency or amounts in the operating room or the in ICU up to POD 2', 'groupDescription': 'A power analysis based on the comparison of a 15% difference in total transfusion amounts up to POD 2 between the treatment groups indicated a total sample size of 80 with a power of 0.8, confidence interval 0.9, and p= 0.05.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY', 'nonInferiorityComment': "Continuous variables were compared by multivariate linear regression analysis to adjust for possible covariates of intraoperative fluids, age, bypass time, and procedure time. Tukey-Kramer test was then used to compare for specific differences between groups for each variable. Categorical data were compared using Fisher's exact test. All comparisons were made at a significance level of 0.05, and analysis was performed with Minitab version 17)."}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'The outcome measure was the intergroup difference in total transfusion amounts up to post-operative day 2.', 'unitOfMeasure': 'mililiters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'equality in both arms'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tranexamic Acid', 'description': 'Tranexamic Acid: Infusion during cardiac surgery'}, {'id': 'FG001', 'title': 'Aminocaproic Acid', 'description': 'Aminocaproic Acid: Infusion during cardiac surgery'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}], 'recruitmentDetails': 'Adult patients scheduled for primary cardiac surgery utilizing CPB at LLUMC . Subjects myst be \\>30 kg, be able to understand English, and sign the consent form.Subjects will be recruited in the pre-admitting area prior to going to the PDCU area in the operating room.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Tranexamic Acid', 'description': 'Tranexamic Acid: Infusion during cardiac surgery'}, {'id': 'BG001', 'title': 'Aminocaproic Acid', 'description': 'Aminocaproic Acid: Infusion during cardiac surgery'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'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': '18', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.79175', 'spread': '13.1260508', 'groupId': 'BG000'}, {'value': '63.25333', 'spread': '12.62622', 'groupId': 'BG001'}, {'value': '63.51597561', 'spread': '12.79547179', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-22', 'studyFirstSubmitDate': '2010-11-15', 'resultsFirstSubmitDate': '2016-10-11', 'studyFirstSubmitQcDate': '2010-11-24', 'lastUpdatePostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-12', 'studyFirstPostDateStruct': {'date': '2010-11-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Transfusion Amounts', 'timeFrame': '48 hours', 'description': 'The outcome measure was the intergroup difference in total transfusion amounts up to post-operative day 2.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cardiac Surgery', 'Antifibrinolytic agents', 'Blood transfusion', 'epsilon aminocaproic acid', 'tranexamic acid'], 'conditions': ['Cardiopulmonary Bypass']}, 'descriptionModule': {'briefSummary': 'We designed a prospective double-blinded randomized trial in an attempt to detect a difference between tranexamic acid (TXA) and epsilon aminocaproic acid (EACA) in reducing transfusion in patients undergoing cardiac surgery.', 'detailedDescription': 'Background: This study compares the efficacy of tranexamic acid (TXA) to epsilon aminocaproic acid (EACA) in reducing blood loss in patients undergoing cardiac surgery. Methods: This was a double-blinded randomized trial. Patients (n=100) undergoing cardi- ac surgery were randomized to receive either TXA (10 mg/kg bolus followed by an infu- sion of 1mg/kg/hr) or EACA (150mg/kg bolus followed by an infusion of 20 mg/kg/hr). The primary outcome measure was a difference in transfusion amounts.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Is the subject 18 years of age or older?\n2. Is the subject scheduled for primary cardiac surgery utilizing cardiopulmonary bypass(CPB)?\n3. Is the subject more than 30 kg ( 66 lbs)?\n4. Does subject understand English?\n\nExclusion Criteria:\n\n1. Does the subject have existing coagulation defects (INR \\> 1.5, platelets \\< 100 ?\n2. Does the subject have renal failure (defined as BUN/Cr ratio 20:1 ?\n3. Does the subject have severe liver disease (AST \\& ALT\\> 3x normal) ?\n4. Is the subject having emergency cardiac surgery, complex aortic surgery, combination valve/CABG surgeries, or redo cardiac surgery?\n5. Is the subject having any procedure where CPB is not anticipated?\n6. Is the patient weight greater than 150 kg?'}, 'identificationModule': {'nctId': 'NCT01248104', 'briefTitle': 'Comparison of Tranexamic to Epsilon Aminocaproic Acid: a Prospective Analysis of Blood Conservation in Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Loma Linda University'}, 'officialTitle': 'Comparison of Tranexamic to Epsilon Aminocaproic Acid: a Prospective Analysis of Blood Conservation in Cardiac Surgery', 'orgStudyIdInfo': {'id': '5100064'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tranexamic Acid', 'description': 'The research pharmacist used computer randomization to assign patients to receive either TXA or EACA. The TXA group re- ceived a bolus of 10 mg / kg over 15 minutes fol- lowed by an infusion of 1 mg/kg/hr.', 'interventionNames': ['Drug: Tranexamic Acid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aminocaproic Acid', 'description': 'The research pharmacist used computer randomization to assign patients to receive either TXA or EACA. The EACA group received a bolus of 100 mg / kg given over 15 minutes shortly after induction of anesthesia followed by an infusion of 10 mg/kg/hr.', 'interventionNames': ['Drug: Aminocaproic Acid']}], 'interventions': [{'name': 'Tranexamic Acid', 'type': 'DRUG', 'otherNames': ['TXA'], 'description': 'Infusion during cardiac surgery', 'armGroupLabels': ['Tranexamic Acid']}, {'name': 'Aminocaproic Acid', 'type': 'DRUG', 'otherNames': ['Amicar'], 'description': 'Infusion during cardiac surgery', 'armGroupLabels': ['Aminocaproic Acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}], 'overallOfficials': [{'name': 'Jason Gatling, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loma Linda University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loma Linda University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Jason Gatling, MD', 'investigatorAffiliation': 'Loma Linda University'}}}}