Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-02-26 @ 6:52 AM
Study NCT ID:
NCT02286102
Status:
COMPLETED
Last Update Posted:
2019-10-29
First Post:
2014-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Prospective Randomized Study on the Clinical Benefits of OrthoPAT Drains
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rosst@hss.edu', 'phone': '212 606-1723', 'title': 'Oheneba Boachie-Adjei, MD', 'organization': 'Hospital for Special Surgery'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'From time of surgery to post-op day 3.', 'eventGroups': [{'id': 'EG000', 'title': 'OrthoPAT', 'description': 'Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours.\n\nOrthoPAT: OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Constavac', 'description': 'Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.\n\nConstavac: Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Volume of Allogenic Blood Transfused Postoperatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Constavac', 'description': 'Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.\n\nConstavac: Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively'}, {'id': 'OG001', 'title': 'OrthoPAT', 'description': 'Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours.\n\nOrthoPAT: OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively'}], 'classes': [{'categories': [{'measurements': [{'value': '458.33', 'spread': '4.28', 'groupId': 'OG000'}, {'value': '382.35', 'spread': '62.22', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours postoperative', 'description': 'The total volume of allogenic blood transfused postoperatively will be measured during the first 48 hours postoperatively while the drains are in place.', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hemoglobin Levels, Post-Op Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Constavac', 'description': 'Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.\n\nConstavac: Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively'}, {'id': 'OG001', 'title': 'OrthoPAT', 'description': 'Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours.\n\nOrthoPAT: OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively'}], 'classes': [{'categories': [{'measurements': [{'value': '9.07', 'spread': '.79', 'groupId': 'OG000'}, {'value': '9.9', 'spread': '.99', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 days postop', 'description': 'Hemoglobin levels will be measured post-operatively day 3', 'unitOfMeasure': 'g/Dl (grams/deciliter)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hemoglobin Levels, Post-Op Day 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Constavac', 'description': 'Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.\n\nConstavac: Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively'}, {'id': 'OG001', 'title': 'OrthoPAT', 'description': 'Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours.\n\nOrthoPAT: OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively'}], 'classes': [{'categories': [{'measurements': [{'value': '9.33', 'spread': '.88', 'groupId': 'OG000'}, {'value': '10.19', 'spread': '1.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 days postop', 'description': 'Hemoglobin levels will be measured post-operatively day 2', 'unitOfMeasure': 'g/Dl (grams/deciliter)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Constavac', 'description': 'Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.\n\nConstavac: Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively'}, {'id': 'FG001', 'title': 'OrthoPAT', 'description': 'Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours.\n\nOrthoPAT: OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Screen Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Constavac', 'description': 'Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.\n\nConstavac: Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively'}, {'id': 'BG001', 'title': 'OrthoPAT', 'description': 'Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours.\n\nOrthoPAT: OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively'}, {'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': '35', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2016-10-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-25', 'studyFirstSubmitDate': '2014-11-05', 'resultsFirstSubmitDate': '2017-03-21', 'studyFirstSubmitQcDate': '2014-11-05', 'lastUpdatePostDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-26', 'studyFirstPostDateStruct': {'date': '2014-11-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Volume of Allogenic Blood Transfused Postoperatively', 'timeFrame': '48 hours postoperative', 'description': 'The total volume of allogenic blood transfused postoperatively will be measured during the first 48 hours postoperatively while the drains are in place.'}], 'secondaryOutcomes': [{'measure': 'Hemoglobin Levels, Post-Op Day 3', 'timeFrame': '3 days postop', 'description': 'Hemoglobin levels will be measured post-operatively day 3'}, {'measure': 'Hemoglobin Levels, Post-Op Day 2', 'timeFrame': '2 days postop', 'description': 'Hemoglobin levels will be measured post-operatively day 2'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Spine Deformity']}, 'descriptionModule': {'briefSummary': 'The examination of the ability of the OrthoPAT® blood collection device to decrease the transfusion rate and volume of adults undergoing posterior spine surgery for deformity correction of 6 levels or more.', 'detailedDescription': 'The purpose of this study is to investigate the use of postoperative drains with blood salvage capabilities to determine if they decrease both the volume and rate of allogenic blood transfusion in adult patients undergoing multilevel spine surgery for deformity. In addition, the ability of these drains to decrease the complications that are associated with allogenic blood exposure (postoperative infection, volume overload and transfusion reactions) will also be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe patient is at least 18 years of age The patient is to undergo posterior spine surgery in the thoracic or lumbar region for deformity correction of greater than 6 levels The patient has signed a patient Informed Consent\n\nExclusion Criteria:\n\nThe patient is less than 18 years of age The patient has a hematologic disorder of any etiology The patient has received active anticoagulant therapy, including aspirin, Plavix, Heparin, Lovenox or Coumadin within one week of admission The patient has a known active infection or malignancy. The patient has a terminal illness with a life expectancy of less than one year.\n\nThe patient requires immuno-suppressive therapy. The patient is undergoing a combined anterior/posterior fusion. The patient has a history of drug or alcohol abuse that may interfere with his/her ability to provide written informed consent.'}, 'identificationModule': {'nctId': 'NCT02286102', 'briefTitle': 'A Prospective Randomized Study on the Clinical Benefits of OrthoPAT Drains', 'organization': {'class': 'OTHER', 'fullName': 'Hospital for Special Surgery, New York'}, 'officialTitle': 'A Prospective Randomized Study on the Clinical Benefits of OrthoPAT Drains for Adults Undergoing Multilevel Spine Surgery for Deformity', 'orgStudyIdInfo': {'id': '2014-363'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OrthoPAT', 'description': 'Patients in the experimental group will receive OrthoPAT drains, which will be used to collect and retransfuse postoperative blood loss. Drains will be removed after 48 hours.', 'interventionNames': ['Device: OrthoPAT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Constavac', 'description': 'Patients identified as active comparator will receive standard Constavac drains, which will be removed after 48 hours.', 'interventionNames': ['Device: Constavac']}], 'interventions': [{'name': 'OrthoPAT', 'type': 'DEVICE', 'description': 'OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively', 'armGroupLabels': ['OrthoPAT']}, {'name': 'Constavac', 'type': 'DEVICE', 'description': 'Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively', 'armGroupLabels': ['Constavac']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'The Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Tom Ross, RN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hospital for Special Surgery, New York'}, {'name': 'Han Jo Kim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital for Special Surgery, New York'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital for Special Surgery, New York', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}