Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-30 @ 6:55 AM
Study NCT ID:
NCT01330433
Status:
COMPLETED
Last Update Posted:
2016-12-15
First Post:
2011-03-31
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D000267', 'term': 'Tissue Adhesions'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'vayermiller@llu.edu', 'phone': '909-558-4355', 'title': 'Research Coordinator', 'organization': 'Loma Linda University, Dept of Cardiovascular and Thoracic Surgery'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'No CoSeal Surgical Spray', 'description': 'A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.', 'otherNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'CoSeal Spray Group', 'description': 'CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.\n\nCoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.\n\nThe dose regimen is as follows:\n\n* Patients weighing \\< 3kg will receive 1ml of CoSeal\n* Patients weighing 3-10kg will receive 1-2ml of CoSeal\n* Patients weighing \\>10kg will receive 2-4ml of CoSeal', 'otherNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'Cardiac Arrest unrelated to device', 'notes': 'Cardiac Arrest related to complex congenital heart disease which has a 10% mortality rate.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Severity of Adhesions at the Retrosternal Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No CoSeal Surgical Spray', 'description': 'A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.'}, {'id': 'OG001', 'title': 'CoSeal Spray Group', 'description': 'CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.\n\nCoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.\n\nThe dose regimen is as follows:\n\n* Patients weighing \\< 3kg will receive 1ml of CoSeal\n* Patients weighing 3-10kg will receive 1-2ml of CoSeal\n* Patients weighing \\>10kg will receive 2-4ml of CoSeal'}], 'classes': [{'title': 'no adhesions', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '31.3', 'groupId': 'OG001'}]}]}, {'title': 'filmy and avascular', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '37.5', 'groupId': 'OG001'}]}]}, {'title': 'requiring blunt dissection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '18.8', 'groupId': 'OG001'}]}]}, {'title': 'requiring sharp dissection', 'categories': [{'measurements': [{'value': '78.6', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}]}]}, {'title': 'requiring extensive sharp dissection', 'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery', 'description': 'Severity of adhesions at seven predefined sites (pericardial or retrosternal, inferior or diaphragmatic region, right lateral or arterial region, region around great vessels). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Severity of Adhesions at the Arterial Base Site.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No CoSeal Surgical Spray', 'description': 'A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.'}, {'id': 'OG001', 'title': 'CoSeal Spray Group', 'description': 'CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.\n\nCoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.\n\nThe dose regimen is as follows:\n\n* Patients weighing \\< 3kg will receive 1ml of CoSeal\n* Patients weighing 3-10kg will receive 1-2ml of CoSeal\n* Patients weighing \\>10kg will receive 2-4ml of CoSeal'}], 'classes': [{'title': 'no adhesions', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '12.5', 'groupId': 'OG001'}]}]}, {'title': 'filmy and avascular', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '43.8', 'groupId': 'OG001'}]}]}, {'title': 'requiring blunt dissection', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'requiring sharp dissection', 'categories': [{'measurements': [{'value': '57.1', 'groupId': 'OG000'}, {'value': '18.8', 'groupId': 'OG001'}]}]}, {'title': 'requiring extensive sharp dissection', 'categories': [{'measurements': [{'value': '35.7', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery', 'description': 'Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Severity of Adhesions at the Diaphragm Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No CoSeal Surgical Spray', 'description': 'A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.'}, {'id': 'OG001', 'title': 'CoSeal Spray Group', 'description': 'CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.\n\nCoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.\n\nThe dose regimen is as follows:\n\n* Patients weighing \\< 3kg will receive 1ml of CoSeal\n* Patients weighing 3-10kg will receive 1-2ml of CoSeal\n* Patients weighing \\>10kg will receive 2-4ml of CoSeal'}], 'classes': [{'title': 'no adhesions', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'filmy and avascular', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '85.7', 'groupId': 'OG001'}]}]}, {'title': 'requiring blunt dissection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '14.3', 'groupId': 'OG001'}]}]}, {'title': 'requiring sharp dissection', 'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'requiring extensive sharp dissection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery', 'description': 'Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Severity of Adhesions at the Left Lateral Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No CoSeal Surgical Spray', 'description': 'A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.'}, {'id': 'OG001', 'title': 'CoSeal Spray Group', 'description': 'CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.\n\nCoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.\n\nThe dose regimen is as follows:\n\n* Patients weighing \\< 3kg will receive 1ml of CoSeal\n* Patients weighing 3-10kg will receive 1-2ml of CoSeal\n* Patients weighing \\>10kg will receive 2-4ml of CoSeal'}], 'classes': [{'title': 'no adhesions', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}]}]}, {'title': 'filmy and avascular', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}, {'title': 'requiring blunt dissection', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8.3', 'groupId': 'OG001'}]}]}, {'title': 'requiring sharp dissection', 'categories': [{'measurements': [{'value': '87.5', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}, {'title': 'requiring extensive sharp dissection', 'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery', 'description': 'Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Severity of Adhesions at the Right Lateral Site', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No CoSeal Surgical Spray', 'description': 'A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.'}, {'id': 'OG001', 'title': 'CoSeal Spray Group', 'description': 'CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.\n\nCoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.\n\nThe dose regimen is as follows:\n\n* Patients weighing \\< 3kg will receive 1ml of CoSeal\n* Patients weighing 3-10kg will receive 1-2ml of CoSeal\n* Patients weighing \\>10kg will receive 2-4ml of CoSeal'}], 'classes': [{'title': 'no adhesions', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6.3', 'groupId': 'OG001'}]}]}, {'title': 'filmy and avascular', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '25.0', 'groupId': 'OG001'}]}]}, {'title': 'requiring blunt dissection', 'categories': [{'measurements': [{'value': '7.7', 'groupId': 'OG000'}, {'value': '50.0', 'groupId': 'OG001'}]}]}, {'title': 'requiring sharp dissection', 'categories': [{'measurements': [{'value': '53.8', 'groupId': 'OG000'}, {'value': '18.8', 'groupId': 'OG001'}]}]}, {'title': 'requiring extensive sharp dissection', 'categories': [{'measurements': [{'value': '38.5', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery', 'description': 'Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Post-operative Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No CoSeal Surgical Spray', 'description': 'A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.'}, {'id': 'OG001', 'title': 'CoSeal Spray Group', 'description': 'CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.\n\nCoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.\n\nThe dose regimen is as follows:\n\n* Patients weighing \\< 3kg will receive 1ml of CoSeal\n* Patients weighing 3-10kg will receive 1-2ml of CoSeal\n* Patients weighing \\>10kg will receive 2-4ml of CoSeal'}], 'classes': [{'categories': [{'measurements': [{'value': '106.38', 'spread': '78.539', 'groupId': 'OG000'}, {'value': '108.64', 'spread': '116.449', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Post-operative bleeding data will be collected on average, during the first 36 hours after the surgery', 'description': 'Post-operative bleeding through surgical site drainage output.', 'unitOfMeasure': 'cm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The difference in the number of participants analyzed and the total number of participants is due to the information not being properly collected at the time of the surgery. Because there was a lack of confidence in the data, it was discarded.'}, {'type': 'PRIMARY', 'title': 'Adhesion Burden', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No CoSeal Surgical Spray', 'description': 'A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.'}, {'id': 'OG001', 'title': 'CoSeal Spray Group', 'description': 'CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.\n\nCoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.\n\nThe dose regimen is as follows:\n\n* Patients weighing \\< 3kg will receive 1ml of CoSeal\n* Patients weighing 3-10kg will receive 1-2ml of CoSeal\n* Patients weighing \\>10kg will receive 2-4ml of CoSeal'}], 'classes': [{'categories': [{'measurements': [{'value': '37.39', 'spread': '10.445', 'groupId': 'OG000'}, {'value': '23.44', 'spread': '6.366', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Time it takes for patient to be put on bypass (an average time between 0 and 120 minutes)', 'description': 'Skin to bypass time as an indicator of adhesion burden.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'No CoSeal Surgical Spray', 'description': 'A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.'}, {'id': 'OG001', 'title': 'CoSeal Spray Group', 'description': 'CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.\n\nCoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.\n\nThe dose regimen is as follows:\n\n* Patients weighing \\< 3kg will receive 1ml of CoSeal\n* Patients weighing 3-10kg will receive 1-2ml of CoSeal\n* Patients weighing \\>10kg will receive 2-4ml of CoSeal'}], 'classes': [{'categories': [{'measurements': [{'value': '4.75', 'spread': '2.832', 'groupId': 'OG000'}, {'value': '6.29', 'spread': '5.269', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Length of stay after second surgery up to 1 month', 'description': 'Number of days post surgery.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The difference in the number of participants analyzed and the total number of participants is due to feeding issues unrelated to the surgery or the device that required the subject to remain hospitalized longer than anticipated.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'No CoSeal Surgical Spray', 'description': 'A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.'}, {'id': 'FG001', 'title': 'CoSeal Spray Group', 'description': 'CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.\n\nCoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.\n\nThe dose regimen is as follows:\n\n* Patients weighing \\< 3kg will receive 1ml of CoSeal\n* Patients weighing 3-10kg will receive 1-2ml of CoSeal\n* Patients weighing \\>10kg will receive 2-4ml of CoSeal'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'No CoSeal Surgical Spray', 'description': 'A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.'}, {'id': 'BG001', 'title': 'CoSeal Spray Group', 'description': 'CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.\n\nCoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.\n\nThe dose regimen is as follows:\n\n* Patients weighing \\< 3kg will receive 1ml of CoSeal\n* Patients weighing 3-10kg will receive 1-2ml of CoSeal\n* Patients weighing \\>10kg will receive 2-4ml of CoSeal'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', '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': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '1', 'groupId': 'BG001', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '1', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-24', 'studyFirstSubmitDate': '2011-03-31', 'resultsFirstSubmitDate': '2016-07-14', 'studyFirstSubmitQcDate': '2011-04-05', 'lastUpdatePostDateStruct': {'date': '2016-12-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-07-14', 'studyFirstPostDateStruct': {'date': '2011-04-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Severity of Adhesions at the Retrosternal Site', 'timeFrame': 'Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery', 'description': 'Severity of adhesions at seven predefined sites (pericardial or retrosternal, inferior or diaphragmatic region, right lateral or arterial region, region around great vessels). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).'}, {'measure': 'Severity of Adhesions at the Arterial Base Site.', 'timeFrame': 'Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery', 'description': 'Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).'}, {'measure': 'Severity of Adhesions at the Diaphragm Site', 'timeFrame': 'Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery', 'description': 'Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).'}, {'measure': 'Severity of Adhesions at the Left Lateral Site', 'timeFrame': 'Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery', 'description': 'Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).'}, {'measure': 'Severity of Adhesions at the Right Lateral Site', 'timeFrame': 'Severity of adhesions data will be collected during approximately the first 30-60 minutes of the second staged surgery', 'description': 'Severity of adhesions at five predefined sites (retrosternal, diaphragmatic region, right lateral, left lateral, arterial base). Severity of adhesions is graded as 0 = no adhesions, 1 = filmy and avascular, 2 = requiring blunt dissection, 3 = requiring sharp dissection, 4 = requiring extensive sharp dissection. Adhesion scores for each patient will be derived from the sum of adhesion severity scores at each site, from 0 (no adhesions) to 28 (cohesive adhesions at all sites).'}, {'measure': 'Post-operative Bleeding', 'timeFrame': 'Post-operative bleeding data will be collected on average, during the first 36 hours after the surgery', 'description': 'Post-operative bleeding through surgical site drainage output.'}, {'measure': 'Adhesion Burden', 'timeFrame': 'Time it takes for patient to be put on bypass (an average time between 0 and 120 minutes)', 'description': 'Skin to bypass time as an indicator of adhesion burden.'}], 'secondaryOutcomes': [{'measure': 'Hospital Stay', 'timeFrame': 'Length of stay after second surgery up to 1 month', 'description': 'Number of days post surgery.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Congenital Heart Defect', 'Surgery-Induced Tissue Adhesions', 'Hemorrhage']}, 'descriptionModule': {'briefSummary': 'This is a prospective, randomized, open-label, blinded-evaluator study that will evaluate the effectiveness of a surgical sealant (CoSeal) composed of biocompatible polyethylene glycol on the formation of mediastinal and pericardial adhesions in children undergoing staged surgical reconstruction (potential procedures include: Blalock-Taussig Type Operation, Classical Glenn Procedure, Bidirectional Glenn Procedure, Norwood). Additionally, bleeding will be evaluated by drainage post-operatively through surgical site drainage output.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have an acceptable surrogate capable of giving consent on the subject's behalf.\n* Pediatric patients ages 0 - 17\n* Have a cardiac disease which requires staged cardiac surgery and resternotomy\n* Non-emergent state or emergent state with sufficient time to educate and consent\n\nExclusion Criteria:\n\n* An immune system disorder\n* Unplanned reoperation\n* Known hypersensitivity to components in CoSeal\n* Patients undergoing reoperation less than 3 months after the primary surgery"}, 'identificationModule': {'nctId': 'NCT01330433', 'briefTitle': 'Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Loma Linda University'}, 'officialTitle': 'Effects of CoSeal in Reducing Perioperative Bleeding & Adhesions in Pediatric Heart Surgery', 'orgStudyIdInfo': {'id': '5110074'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'No CoSeal Surgical Spray', 'description': 'A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.'}, {'type': 'EXPERIMENTAL', 'label': 'CoSeal Spray Group', 'description': 'CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.', 'interventionNames': ['Device: CoSeal Surgical Spray Group']}], 'interventions': [{'name': 'CoSeal Surgical Spray Group', 'type': 'DEVICE', 'description': 'A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.\n\nThe dose regimen is as follows:\n\n* Patients weighing \\< 3kg will receive 1ml of CoSeal\n* Patients weighing 3-10kg will receive 1-2ml of CoSeal\n* Patients weighing \\>10kg will receive 2-4ml of CoSeal', 'armGroupLabels': ['CoSeal Spray Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92602', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}], 'overallOfficials': [{'name': 'Nahidh Hasaniya, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Loma Linda University Medical Center'}, {'name': 'Anees Razzouk, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Loma Linda University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Loma Linda University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Nahidh Hasaniya', 'investigatorAffiliation': 'Loma Linda University'}}}}