Ignite Creation Date:
2025-12-24 @ 12:54 PM
Ignite Modification Date:
2026-01-03 @ 6:51 PM
Study NCT ID:
NCT03376061
Status:
COMPLETED
Last Update Posted:
2021-02-11
First Post:
2017-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D016063', 'term': 'Blood Loss, Surgical'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007431', 'term': 'Intraoperative Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Austin.Browne@phri.ca', 'phone': '19055212100', 'title': 'Research assistant', 'phoneExt': '40582', 'organization': 'Population Health Research Institute'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Due to the small sample size (N\\<100 patients) the DEPOSITION pilot trial is not sufficiently powered to detect statistically significant differences between topical and intravenous TxA groups.'}}, 'adverseEventsModule': {'timeFrame': '30 days post-operatively', 'eventGroups': [{'id': 'EG000', 'title': 'Topical TxA (Intervention)', 'description': '50 mL of topical tranexamic acid (equivalent to 5 g TxA) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. In addition, patients received intravenous placebo (saline) administered as per anesthetist standard of care.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 0, 'seriousNumAtRisk': 49, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intravenous TxA (Control)', 'description': 'Up to 100 mL of intravenous tranexamic acid (equivalent to 10 g TxA) administered as per anesthetist standard of care. In addition, patients will receive topical placebo (saline) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure.', 'otherNumAtRisk': 48, 'deathsNumAtRisk': 48, 'otherNumAffected': 0, 'seriousNumAtRisk': 48, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Median Volume of Mediastinal Fluid Collected From Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical TxA (Intervention)', 'description': '50 mL of topical tranexamic acid (equivalent to 5 g TxA) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. In addition, patients received intravenous placebo (saline) administered as per anesthetist standard of care.'}, {'id': 'OG001', 'title': 'Intravenous TxA (Control)', 'description': 'Up to 100 mL of intravenous tranexamic acid (equivalent to 10 g TxA) administered as per anesthetist standard of care. In addition, patients will receive topical placebo (saline) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure.'}], 'classes': [{'categories': [{'measurements': [{'value': '500', 'groupId': 'OG000', 'lowerLimit': '350', 'upperLimit': '750'}, {'value': '540', 'groupId': 'OG001', 'lowerLimit': '420', 'upperLimit': '700'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Fluid collected in the first 24 hours after the surgical procedure', 'description': 'Cumulative volume (mL) of fluid collected from mediastinal drainage tubes 24 hours after the surgical procedure', 'unitOfMeasure': 'mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Seizures', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical TxA (Intervention)', 'description': '50 mL of topical tranexamic acid (equivalent to 5 g TxA) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. In addition, patients received intravenous placebo (saline) administered as per anesthetist standard of care.'}, {'id': 'OG001', 'title': 'Intravenous TxA (Control)', 'description': 'Up to 100 mL of intravenous tranexamic acid (equivalent to 10 g TxA) administered as per anesthetist standard of care. In addition, patients will receive topical placebo (saline) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Patients will be followed post-operatively until hospital discharge', 'description': 'Patients experiencing a post-operative seizure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical TxA (Intervention)', 'description': '50 mL of topical tranexamic acid (equivalent to 5 g TxA) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. In addition, patients received intravenous placebo (saline) administered as per anesthetist standard of care.'}, {'id': 'OG001', 'title': 'Intravenous TxA (Control)', 'description': 'Up to 100 mL of intravenous tranexamic acid (equivalent to 10 g TxA) administered as per anesthetist standard of care. In addition, patients will receive topical placebo (saline) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Patients will be followed post-operatively until hospital discharge', 'description': 'The occurrence of death due to any cause', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With RBC Transfusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical TxA (Intervention)', 'description': '50 mL of topical tranexamic acid (equivalent to 5 g TxA) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. In addition, patients received intravenous placebo (saline) administered as per anesthetist standard of care.'}, {'id': 'OG001', 'title': 'Intravenous TxA (Control)', 'description': 'Up to 100 mL of intravenous tranexamic acid (equivalent to 10 g TxA) administered as per anesthetist standard of care. In addition, patients will receive topical placebo (saline) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure.'}], 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Intra-operative and post-operative RBC transfusions', 'description': 'Patients requiring a red blood cell transfusion', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Re-operation for Bleeding or Tamponade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical TxA (Intervention)', 'description': '50 mL of topical tranexamic acid (equivalent to 5 g TxA) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. In addition, patients received intravenous placebo (saline) administered as per anesthetist standard of care.'}, {'id': 'OG001', 'title': 'Intravenous TxA (Control)', 'description': 'Up to 100 mL of intravenous tranexamic acid (equivalent to 10 g TxA) administered as per anesthetist standard of care. In addition, patients will receive topical placebo (saline) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Patients will be followed post-operatively until hospital discharge', 'description': 'Occurrence of re-operation for the purpose of bleeding or cardiac tamponade', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Median Number of Hours Participants Spent in ICU', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical TxA (Intervention)', 'description': '50 mL of topical tranexamic acid (equivalent to 5 g TxA) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. In addition, patients received intravenous placebo (saline) administered as per anesthetist standard of care.'}, {'id': 'OG001', 'title': 'Intravenous TxA (Control)', 'description': 'Up to 100 mL of intravenous tranexamic acid (equivalent to 10 g TxA) administered as per anesthetist standard of care. In addition, patients will receive topical placebo (saline) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '45'}, {'value': '26', 'groupId': 'OG001', 'lowerLimit': '22', 'upperLimit': '53'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Number of hours spent in ICU from arrival to exit (collected at the Post-Operative Visit).', 'description': 'Number of hours participants spent in the intensive care unit (ICU)', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Concentration of TxA in Plasma Collected From Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Topical TxA (Intervention)', 'description': '50 mL of topical tranexamic acid (equivalent to 5 g TxA) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. In addition, patients will receive intravenous placebo (saline) administered as per anesthetist standard of care.'}, {'id': 'OG001', 'title': 'Intravenous TxA (Control)', 'description': 'Up to 100 mL of intravenous tranexamic acid (equivalent to 10 g TxA) administered as per anesthetist standard of care. In addition, patients will receive topical placebo (saline) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.58', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '1.10', 'spread': '0.52', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'on arrival in ICU within 3 hours', 'description': 'Plasma TxA concentrations measured from blood samples taken upon arrival in the ICU', 'unitOfMeasure': 'microgram per milliliter per kilogram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '4 patients from the topical TxA group and 3 patients from the intravenous TxA group were excluded because they either did not receive a TxA dose or received an incomplete TxA dose.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Topical TxA (Intervention)', 'description': '50 mL of topical tranexamic acid (equivalent to 5 g TxA) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. In addition, patients received intravenous placebo (saline) administered as per anesthetist standard of care.'}, {'id': 'FG001', 'title': 'Intravenous TxA (Control)', 'description': 'Up to 100 mL of intravenous tranexamic acid (equivalent to 10 g TxA) administered as per anesthetist standard of care. In addition, patients will receive topical placebo (saline) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Between December 2017 and April 2018 a total of 97 patients were randomized to the topical (n = 49) and intravenous (n = 48) groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Topical TxA (Intervention)', 'description': '50 mL of topical tranexamic acid (equivalent to 5 g TxA) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure. In addition, patients will receive intravenous placebo (saline) administered as per anesthetist standard of care.'}, {'id': 'BG001', 'title': 'Intravenous TxA (Control)', 'description': 'Up to 100 mL of intravenous tranexamic acid (equivalent to 10 g TxA) administered as per anesthetist standard of care. In addition, patients will receive topical placebo (saline) poured into the pericardial and mediastinal cavities in 2 equal doses: 25 mL when the patient comes off-pump and the remaining 25 mL before sternotomy closure.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.3', 'spread': '9.4', 'groupId': 'BG000'}, {'value': '67.8', 'spread': '9.2', 'groupId': 'BG001'}, {'value': '67.5', 'spread': '9.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White/Caucasian', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '46', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic/Latino', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Southeast Asian/Malaysian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Aboriginal/Native Persons', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '48', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Diabetes mellitus', 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Stroke', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Transient ischemic attack', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Carotid endarterectomy/stent', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of seizures', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'New oral anticoagulants (NOAC)', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Aspirin', 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Clopidogrel (Plavix)', 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ticagrelor', 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-03-16', 'size': 251139, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-05-27T14:50', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The pharmacy will prepare 1 syringe of 50 ml of topical TA (5 g) or placebo. They will also prepare for the same patient 2 syringes of 50 ml (5 g) for intravenous (i.v.) injection or placebo. TA is similar in all aspects to normal saline. Blinding of both teams will be easy. The syringes will be prepared and randomized in pharmacy before the surgery.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Tranexamic Acid intravenous + Placebo topical versus Placebo intravenous + Tranexamic Acid topical'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-26', 'studyFirstSubmitDate': '2017-11-17', 'resultsFirstSubmitDate': '2019-05-28', 'studyFirstSubmitQcDate': '2017-12-12', 'lastUpdatePostDateStruct': {'date': '2021-02-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-01', 'studyFirstPostDateStruct': {'date': '2017-12-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Median Volume of Mediastinal Fluid Collected From Participants', 'timeFrame': 'Fluid collected in the first 24 hours after the surgical procedure', 'description': 'Cumulative volume (mL) of fluid collected from mediastinal drainage tubes 24 hours after the surgical procedure'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Seizures', 'timeFrame': 'Patients will be followed post-operatively until hospital discharge', 'description': 'Patients experiencing a post-operative seizure'}, {'measure': 'Number of Participants With Mortality', 'timeFrame': 'Patients will be followed post-operatively until hospital discharge', 'description': 'The occurrence of death due to any cause'}, {'measure': 'Number of Participants With RBC Transfusion', 'timeFrame': 'Intra-operative and post-operative RBC transfusions', 'description': 'Patients requiring a red blood cell transfusion'}, {'measure': 'Number of Participants With Re-operation for Bleeding or Tamponade', 'timeFrame': 'Patients will be followed post-operatively until hospital discharge', 'description': 'Occurrence of re-operation for the purpose of bleeding or cardiac tamponade'}, {'measure': 'Median Number of Hours Participants Spent in ICU', 'timeFrame': 'Number of hours spent in ICU from arrival to exit (collected at the Post-Operative Visit).', 'description': 'Number of hours participants spent in the intensive care unit (ICU)'}, {'measure': 'Mean Concentration of TxA in Plasma Collected From Participants', 'timeFrame': 'on arrival in ICU within 3 hours', 'description': 'Plasma TxA concentrations measured from blood samples taken upon arrival in the ICU'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tranexamic Acid', 'Cardiac surgery'], 'conditions': ['Bleeding', 'Surgical Blood Loss']}, 'referencesModule': {'references': [{'pmid': '3766524', 'type': 'BACKGROUND', 'citation': 'Kucuk O, Kwaan HC, Frederickson J, Wade L, Green D. Increased fibrinolytic activity in patients undergoing cardiopulmonary bypass operation. Am J Hematol. 1986 Nov;23(3):223-9. doi: 10.1002/ajh.2830230306.'}, {'pmid': '6448643', 'type': 'BACKGROUND', 'citation': 'Harker LA, Malpass TW, Branson HE, Hessel EA 2nd, Slichter SJ. Mechanism of abnormal bleeding in patients undergoing cardiopulmonary bypass: acquired transient platelet dysfunction associated with selective alpha-granule release. Blood. 1980 Nov;56(5):824-34. No abstract available.'}, {'pmid': '8283896', 'type': 'BACKGROUND', 'citation': 'Despotis GJ, Santoro SA, Spitznagel E, Kater KM, Cox JL, Barnes P, Lappas DG. Prospective evaluation and clinical utility of on-site monitoring of coagulation in patients undergoing cardiac operation. J Thorac Cardiovasc Surg. 1994 Jan;107(1):271-9.'}, {'pmid': '7508070', 'type': 'BACKGROUND', 'citation': 'Lemmer JH Jr, Stanford W, Bonney SL, Breen JF, Chomka EV, Eldredge WJ, Holt WW, Karp RB, Laub GW, Lipton MJ, et al. Aprotinin for coronary bypass operations: efficacy, safety, and influence on early saphenous vein graft patency. A multicenter, randomized, double-blind, placebo-controlled study. J Thorac Cardiovasc Surg. 1994 Feb;107(2):543-51; discussion 551-3.'}, {'pmid': '16400465', 'type': 'BACKGROUND', 'citation': 'Santos AT, Kalil RA, Bauemann C, Pereira JB, Nesralla IA. A randomized, double-blind, and placebo-controlled study with tranexamic acid of bleeding and fibrinolytic activity after primary coronary artery bypass grafting. Braz J Med Biol Res. 2006 Jan;39(1):63-9. doi: 10.1590/s0100-879x2006000100007. Epub 2005 Dec 15.'}, {'pmid': '12651635', 'type': 'BACKGROUND', 'citation': 'Pleym H, Stenseth R, Wahba A, Bjella L, Karevold A, Dale O. Single-dose tranexamic acid reduces postoperative bleeding after coronary surgery in patients treated with aspirin until surgery. Anesth Analg. 2003 Apr;96(4):923-928. doi: 10.1213/01.ANE.0000054001.37346.03.'}, {'pmid': '27774838', 'type': 'BACKGROUND', 'citation': 'Myles PS, Smith JA, Forbes A, Silbert B, Jayarajah M, Painter T, Cooper DJ, Marasco S, McNeil J, Bussieres JS, McGuinness S, Byrne K, Chan MT, Landoni G, Wallace S; ATACAS Investigators of the ANZCA Clinical Trials Network. Tranexamic Acid in Patients Undergoing Coronary-Artery Surgery. N Engl J Med. 2017 Jan 12;376(2):136-148. doi: 10.1056/NEJMoa1606424. Epub 2016 Oct 23.'}, {'pmid': '19020118', 'type': 'BACKGROUND', 'citation': 'Martin K, Wiesner G, Breuer T, Lange R, Tassani P. The risks of aprotinin and tranexamic acid in cardiac surgery: a one-year follow-up of 1188 consecutive patients. Anesth Analg. 2008 Dec;107(6):1783-90. doi: 10.1213/ane.0b013e318184bc20.'}, {'pmid': '22054656', 'type': 'BACKGROUND', 'citation': 'Kalavrouziotis D, Voisine P, Mohammadi S, Dionne S, Dagenais F. High-dose tranexamic acid is an independent predictor of early seizure after cardiopulmonary bypass. Ann Thorac Surg. 2012 Jan;93(1):148-54. doi: 10.1016/j.athoracsur.2011.07.085. Epub 2011 Nov 4.'}]}, 'descriptionModule': {'briefSummary': 'The aim is to conduct a double-blinded single-centre randomized controlled clinical trial of application of topical dose of tranexamic acid (TA) versus the usual intravenous TA in patients undergoing cardiac surgery at the Hamilton General Hospital. This pilot study will assess the feasibility to perform a large randomized international trial exploring this objective.', 'detailedDescription': 'Postoperative bleeding related to open cardiac surgery increases the rates of complications and mortality. It results from the blood thinners that are needed for use. Intravenous tranexamic acid (TA) has become a mainstay in cardiac surgical procedures for decreasing bleeding and minimizing transfusion requirements. Although intravenous TA is usually well tolerated, there is a well-known risk (1 to 4%) of postoperative seizures. This is due to the similarity between TA and the brain tissues. The aim is to eliminate the risk of seizures but to maintain the protection against bleeding. When TA is used directly on the tissues (topically) for other type of surgeries (joints), TA is effective to reduce blood loss and transfusions. The aim is to prove that direct application of TA on the heart can eliminate postoperative seizures and reduce the amount of blood transfusions in patients who have cardiac surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female \\>= 18 years old\n* Undergoing cardiac surgical procedure with the use of cardiopulmonary bypass and median sternotomy\n* Provide written informed consent\n\nExclusion Criteria:\n\n* Poor (English) language comprehension\n* Minimally invasive valve surgery\n* Off-pump procedures\n* Emergency operations\n* Known history of increased bleeding disorder\n* Thromboembolic disease\n* Allergy to tranexamic acid\n* Severe renal impairment (eGFR \\<30 mL/min/1.73m2 )'}, 'identificationModule': {'nctId': 'NCT03376061', 'acronym': 'DEPOSITION', 'briefTitle': 'Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Population Health Research Institute'}, 'officialTitle': 'DEPOSITION: Pilot Study Decreasing Postoperative Blood Loss by Topical vs. Intravenous Tranexamic Acid in Open Cardiac Surgery', 'orgStudyIdInfo': {'id': 'DEPOSITION 1.0 2017-07-28'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TA Topical', 'description': '1 syringe of 50ml of topical Tranexamic Acid (5g) or placebo. The topical will be poured into the pericardial mediastinal cavities in 2 equal doses, 25ml when the pt comes off-pump and the other 25ml before sternotomy is closed.', 'interventionNames': ['Drug: Tranexamic Acid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TA Intravenous', 'description': '2 syringes of 50ml (5mg) Tranexamic Acid for intravenous injection or placebo.', 'interventionNames': ['Drug: Tranexamic Acid']}], 'interventions': [{'name': 'Tranexamic Acid', 'type': 'DRUG', 'otherNames': ['Cyklokapron'], 'description': 'Tranexamic Acid is a medication used to treat or prevent excessive blood loss from major trauma, post partum, surgery, tooth removal, nose bleeds, and heavy menstruation.', 'armGroupLabels': ['TA Intravenous', 'TA Topical']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8L 2X2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hamilton General Hospital', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Andre Lamy, MD MHSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Population Health Research Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Population Health Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}