Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-28 @ 11:37 AM
Study NCT ID:
NCT01656759
Status:
COMPLETED
Last Update Posted:
2016-02-09
First Post:
2012-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Use of a Novel Fibrin Sealant in Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D016063', 'term': 'Blood Loss, Surgical'}, {'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007431', 'term': 'Intraoperative Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D036881', 'term': 'Long-Term Synaptic Depression'}], 'ancestors': [{'id': 'D009473', 'term': 'Neuronal Plasticity'}, {'id': 'D009424', 'term': 'Nervous System Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sean_m_kearns@rush.edu', 'phone': '708-236-2664', 'title': 'Sean Kearns', 'organization': 'Rush University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Control Group', 'description': 'Control group. Will not receive the fibrin spray.', 'otherNumAtRisk': 27, 'otherNumAffected': 0, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment Group--Evicel Fibrin Spray', 'description': 'Patient will receive the fibrin spray after implantation of device but before the wound is closed.\n\nPatients will be randomized to receive spray or not and postop parameters measured.\n\nEvicel Fibrin Spray: 10cc syringe dose, once at the end of TKA', 'otherNumAtRisk': 25, 'otherNumAffected': 0, 'seriousNumAtRisk': 25, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Superficial Wound Dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders'}], 'seriousEvents': [{'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 27, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary--Percent Change of Pre- to Post-Operative Hemoglobin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Control group. Will not receive the fibrin spray.'}, {'id': 'OG001', 'title': 'Treatment Group--Evicel Fibrin Spray', 'description': 'Patient will receive the fibrin spray after implantation of device but before the wound is closed.\n\nPatients will be randomized to receive spray or not and postop parameters measured.\n\nEvicel Fibrin Spray: 10cc syringe dose, once at the end of TKA'}], 'classes': [{'categories': [{'measurements': [{'value': '20.1', 'spread': '7.0', 'groupId': 'OG000'}, {'value': '22.5', 'spread': '5.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Pre-operative to 1 month', 'description': 'Pre-operative hemoglobin values from routine CBC no earlier than 1 month prior to surgery were compared to post-operative hemoglobin values from routine CBC after surgery.', 'unitOfMeasure': 'Percent Change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Total Blood Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Control group. Will not receive the fibrin spray.'}, {'id': 'OG001', 'title': 'Treatment Group--Evicel Fibrin Spray', 'description': 'Patient will receive the fibrin spray after implantation of device but before the wound is closed.\n\nPatients will be randomized to receive spray or not and postop parameters measured.\n\nEvicel Fibrin Spray: 10cc syringe dose, once at the end of TKA'}], 'classes': [{'categories': [{'measurements': [{'value': '605', 'spread': '288', 'groupId': 'OG000'}, {'value': '621', 'spread': '334', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Collected during surgery and in first 2-3 days after surgery', 'description': 'Combination of intraoperative and postoperative blood loss for participants.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Total Transfusions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Control group. Will not receive the fibrin spray.'}, {'id': 'OG001', 'title': 'Treatment Group--Evicel Fibrin Spray', 'description': 'Patient will receive the fibrin spray after implantation of device but before the wound is closed.\n\nPatients will be randomized to receive spray or not and postop parameters measured.\n\nEvicel Fibrin Spray: 10cc syringe dose, once at the end of TKA'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 days', 'description': 'The number of transfusions each patient receives during their postoperative hospitalization.', 'unitOfMeasure': 'Number of transfusions', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Blood Loss', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Group', 'description': 'Control group. Will not receive the fibrin spray.'}, {'id': 'OG001', 'title': 'Treatment Group--Evicel Fibrin Spray', 'description': 'Patient will receive the fibrin spray after implantation of device but before the wound is closed.\n\nPatients will be randomized to receive spray or not and postop parameters measured.\n\nEvicel Fibrin Spray: 10cc syringe dose, once at the end of TKA'}], 'classes': [{'categories': [{'measurements': [{'value': '543', 'spread': '273', 'groupId': 'OG000'}, {'value': '555', 'spread': '324', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '3 days', 'description': 'Measured as drainage output from postoperative drains during hospitalization.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Control Group', 'description': 'Control group. Will not receive the fibrin spray.'}, {'id': 'FG001', 'title': 'Treatment Group--Evicel Fibrin Spray', 'description': 'Patient will receive the fibrin spray after implantation of device but before the wound is closed.\n\nPatients will be randomized to receive spray or not and postop parameters measured.\n\nEvicel Fibrin Spray: 10cc syringe dose, once at the end of TKA'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '25'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'Prior to randomization, 21 patients were disqualified for protocol violation.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Control Group', 'description': 'Control group. Will not receive the fibrin spray.'}, {'id': 'BG001', 'title': 'Treatment Group--Evicel Fibrin Spray', 'description': 'Patient will receive the fibrin spray after implantation of device but before the wound is closed.\n\nPatients will be randomized to receive spray or not and postop parameters measured.\n\nEvicel Fibrin Spray: 10cc syringe dose, once at the end of TKA'}, {'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': '7', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67', 'spread': '9', 'groupId': 'BG000'}, {'value': '64', 'spread': '10', 'groupId': 'BG001'}, {'value': '66', 'spread': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-11', 'studyFirstSubmitDate': '2012-06-14', 'resultsFirstSubmitDate': '2015-10-27', 'studyFirstSubmitQcDate': '2012-07-31', 'lastUpdatePostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-01-11', 'studyFirstPostDateStruct': {'date': '2012-08-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-02-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary--Percent Change of Pre- to Post-Operative Hemoglobin', 'timeFrame': 'Pre-operative to 1 month', 'description': 'Pre-operative hemoglobin values from routine CBC no earlier than 1 month prior to surgery were compared to post-operative hemoglobin values from routine CBC after surgery.'}, {'measure': 'Total Blood Loss', 'timeFrame': 'Collected during surgery and in first 2-3 days after surgery', 'description': 'Combination of intraoperative and postoperative blood loss for participants.'}], 'secondaryOutcomes': [{'measure': 'Total Transfusions', 'timeFrame': '3 days', 'description': 'The number of transfusions each patient receives during their postoperative hospitalization.'}, {'measure': 'Postoperative Blood Loss', 'timeFrame': '3 days', 'description': 'Measured as drainage output from postoperative drains during hospitalization.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Blood Loss', 'Hemoglobin', 'Hematocrit', 'Blood Transfusions'], 'conditions': ['Osteoarthritis', 'Intraoperative Bleeding']}, 'referencesModule': {'references': [{'pmid': '10565650', 'type': 'RESULT', 'citation': 'Levy O, Martinowitz U, Oran A, Tauber C, Horoszowski H. The use of fibrin tissue adhesive to reduce blood loss and the need for blood transfusion after total knee arthroplasty. A prospective, randomized, multicenter study. J Bone Joint Surg Am. 1999 Nov;81(11):1580-8. doi: 10.2106/00004623-199911000-00010.'}, {'pmid': '11679600', 'type': 'RESULT', 'citation': 'Wang GJ, Hungerford DS, Savory CG, Rosenberg AG, Mont MA, Burks SG, Mayers SL, Spotnitz WD. Use of fibrin sealant to reduce bloody drainage and hemoglobin loss after total knee arthroplasty: a brief note on a randomized prospective trial. J Bone Joint Surg Am. 2001 Oct;83(10):1503-5. doi: 10.2106/00004623-200110000-00007.'}]}, 'descriptionModule': {'briefSummary': 'Applying a fibrin spray, after knee device implantation, will help in reducing patient blood loss and decrease the drop in both hemoglobin and hematocrit levels. Also, with decreased blood loss there should be a reduced need for blood transfusions.', 'detailedDescription': "Study Design\n\nStudy design and control methods:\n\nThis study is designed as a prospective, randomized, double-blinded controlled clinical trial to compare the effect of a fibrin spray applied to the surgical wound as compared to patients not receiving the fibrin spray.\n\nTreatment group:\n\nThe subjects will be randomly assigned to the fibrin treatment group or to the control group at the time of the surgery via the opening of a randomly selected sealed envelope. The patient and the independent reviewer will be blinded as to which treatment group the patient is assigned to. This information will be linked to a confidential database for later review by the principal investigator.\n\nTreatment allocation:\n\nAll eligible patients (i.e., meeting inclusion criteria and no exclusion criteria) will be treated and observed per the research protocol. All patients will maintain the right to refuse participation and receive a specific treatment of the study if desired.\n\nTrial Population:\n\nThe target sample size is 70 patients for both the treatment and control groups (140 total) with each group split evenly between males and females. There will be one actively enrolling surgeon (Dr. Brett Levine). The goal is to enroll a total of 140 subjects experiencing joint pain that warrants a Total knee arthroplasty (TKA). The specific diagnosis for the joint pain will not direct the subjects' assignment or eligibility at the time of surgery. All 140 patients will be enrolled from the office of the primary investigator (Dr. Brett Levine). All indications for TKA will be included unless one of the exclusion criteria is met."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must be male or female of any race\n* Ages 18-80 years old\n* Patients must be undergoing an elective, primary knee arthroplasty performed by the principal investigator\n\nExclusion Criteria:\n\n* Allergy or intolerance to the study materials\n* Surgical intervention during the past month for the treatment of the painful joint or its underlying etiology\n* History of previous surgeries on the affected joint including previous arthroscopy (open surgeries)\n* Women that are pregnant or may become pregnant\n* Patient declines to participate'}, 'identificationModule': {'nctId': 'NCT01656759', 'briefTitle': 'Use of a Novel Fibrin Sealant in Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Rush University Medical Center'}, 'officialTitle': 'Use of a Novel Fibrin Sealant in Total Knee Arthroplasty: A Prospective Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '12032202-IRB01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Control group. Will not receive the fibrin spray.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment Group--Evicel Fibrin Spray', 'description': 'Patient will receive the fibrin spray after implantation of device but before the wound is closed.\n\nPatients will be randomized to receive spray or not and postop parameters measured.', 'interventionNames': ['Drug: Evicel Fibrin Spray']}], 'interventions': [{'name': 'Evicel Fibrin Spray', 'type': 'DRUG', 'otherNames': ['Produced by OMRIX Biopharmaceuticals, Ltd.'], 'description': '10cc syringe dose, once at the end of TKA', 'armGroupLabels': ['Treatment Group--Evicel Fibrin Spray']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60304', 'city': 'Oak Park', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush Oak Park Hospital', 'geoPoint': {'lat': 41.88503, 'lon': -87.7845}}], 'overallOfficials': [{'name': 'Brett R Levine, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RUMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rush University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor and Associate Residency Director', 'investigatorFullName': 'Brett Levine, MD', 'investigatorAffiliation': 'Rush University Medical Center'}}}}