Ignite Creation Date:
2025-12-24 @ 11:48 PM
Ignite Modification Date:
2025-12-30 @ 9:36 AM
Study NCT ID:
NCT05340751
Status:
COMPLETED
Last Update Posted:
2023-01-26
First Post:
2018-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Hypotensive Anesthesia on Hemoglobin Levels During Total Knee Arthroplasty
Sponsor:
Organization:
Raw JSON
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Hemoglobin and Hematocrit Levels'}], 'classes': [{'title': '15 min', 'categories': [{'measurements': [{'value': '12.2', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': '30 min', 'categories': [{'measurements': [{'value': '12.0', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': '45 min', 'categories': [{'measurements': [{'value': '11.9', 'spread': '1.595', 'groupId': 'OG000'}]}]}, {'title': '60 min', 'categories': [{'measurements': [{'value': '11.8', 'spread': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'PACU stay', 'categories': [{'measurements': [{'value': '12.0', 'spread': '1', 'groupId': 'OG000'}]}]}, {'title': 'POD1 (24hr)', 'categories': [{'measurements': [{'value': '11.6', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'POD2 (48hr)', 'categories': [{'measurements': [{'value': '11.0', 'spread': '1.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 48 hours after surgery', 'description': 'To investigate the effect of intraoperative fluid substitution during HEA on hemoglobin levels during and after primary TKA.', 'unitOfMeasure': 'g/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Hematocrit (g/dL) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Anesthesia', 'description': 'hemoglobin\n\nBlood drawn: Hemoglobin and Hematocrit Levels'}], 'classes': [{'title': '15 min', 'categories': [{'measurements': [{'value': '36.8', 'spread': '3.2', 'groupId': 'OG000'}]}]}, {'title': '30 min', 'categories': [{'measurements': [{'value': '36', 'spread': '3.1', 'groupId': 'OG000'}]}]}, {'title': '45 min', 'categories': [{'measurements': [{'value': '35.4', 'spread': '2.9', 'groupId': 'OG000'}]}]}, {'title': '60 min', 'categories': [{'measurements': [{'value': '34.7', 'spread': '3.1', 'groupId': 'OG000'}]}]}, {'title': 'PACU', 'categories': [{'measurements': [{'value': '35.1', 'spread': '2.7', 'groupId': 'OG000'}]}]}, {'title': 'POD1 (24hr)', 'categories': [{'measurements': [{'value': '35.3', 'spread': '3.4', 'groupId': 'OG000'}]}]}, {'title': 'POD (48hr)', 'categories': [{'measurements': [{'value': '32.6', 'spread': '3.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 48 hours after surgery', 'description': 'To Investigates the effect of intraoperative fluid substitution during HEA on hematocrit levels during and after primary TKA.', 'unitOfMeasure': 'g/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Anesthesia', 'description': 'hemoglobin\n\nBlood drawn: Hemoglobin and Hematocrit Levels'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Anesthesia', 'description': 'hemoglobin\n\nBlood drawn: Hemoglobin and Hematocrit Levels'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000', 'lowerLimit': '44', 'upperLimit': '79'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2014-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-26', 'studyFirstSubmitDate': '2018-11-23', 'resultsFirstSubmitDate': '2022-04-26', 'studyFirstSubmitQcDate': '2022-04-19', 'lastUpdatePostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-04-26', 'studyFirstPostDateStruct': {'date': '2022-04-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Hemoglobin (in g/dl) Levels', 'timeFrame': 'up to 48 hours after surgery', 'description': 'To investigate the effect of intraoperative fluid substitution during HEA on hemoglobin levels during and after primary TKA.'}, {'measure': 'Hematocrit (g/dL) Levels', 'timeFrame': 'Up to 48 hours after surgery', 'description': 'To Investigates the effect of intraoperative fluid substitution during HEA on hematocrit levels during and after primary TKA.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blood management', 'Blood transfusion', 'Hemoglobin', 'Hypotensive Anesthesia', 'Total Knee Arthroplasty'], 'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'The current study investigates the effect of hypotensive anesthesia on patient hemoglobin levels during primary total knee arthroplasty. Considering that because of the tourniquet there is no blood loss during the first 60 minutes of the procedure changes in hemoglobin during the first 60 minutes should be primarily related to decrease in blood pressure and secondary to fluid loading during hypotensive anesthesia.', 'detailedDescription': 'The specific aim of this prospective study is to collect serial hemoglobin levels intraoperatively during hypotensive anesthesia to evaluate if intraoperative intravenous fluid substitution will change hemoglobin levels during the time the tourniquet is inflated (no blood loss).\n\nThe combination of vasodilation during hypotensive anesthesia and fluid substitution will result in decrease of hemoglobin levels during the tourniquet time.\n\nTubes of 5cc to measure hemoglobin and hematocrit levels preoperatively, prior to inflation of the tourniquet, 15 minutes, 30 minutes, 45 minutes and 60 minutes after tourniquet inflation and in PACU as well as POD 1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients scheduled for primary total knee arthroplasty who meet the qualifications will be consented prior to the surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Non- inflammatory degenerative joint disease of the knee\n* Patients scheduled for unilateral primary total Knee arthroplasty\n* Age between 40 and 80 years\n* Hypotensive spinal-epidural anesthesia with systolic BP \\< 95 and diastolic BP \\< 65.\n* Adequate intraoperative fluid loading: a minimum of 1500 ml IV fluids should be infused during procedure: at least 300 cc/15 minutes.\n\nExclusion Criteria:\n\n* Blood coagulopathies resulting in a hypocoagulable state (hemophilia, von Willebrand disease, etc.)\n* Blood coagulopathies resulting in a hypercoagulable state (factor V leiden, antithrombin III deficiency, protein C deficiency, protein S deficiency)\n* Patients on anti-coagulants (coumadin, plavix, pradaxa, heparin)\n* Congestive Heart Failure (at least one medication to treat congestive heart failure)\n* Coronary artery disease (s/p bypass, stent or AMI)\n* Kidney insufficiency (creatinine \\> 1.5)\n* Aortic or mitral valve disease\n* Pulmonary hypertension\n* Revision Knee Surgery\n* Inadequate intravenous fluid substitution during the procedure 1.5L during 60 minutes.'}, 'identificationModule': {'nctId': 'NCT05340751', 'briefTitle': 'The Effect of Hypotensive Anesthesia on Hemoglobin Levels During Total Knee Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Hospital for Special Surgery, New York'}, 'officialTitle': 'The Effect of Hypotensive Anesthesia on Hemoglobin Levels During Total Knee Arthroplasty', 'orgStudyIdInfo': {'id': '2015-081'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Anesthesia', 'description': 'hemoglobin', 'interventionNames': ['Diagnostic Test: Blood drawn']}], 'interventions': [{'name': 'Blood drawn', 'type': 'DIAGNOSTIC_TEST', 'description': 'Hemoglobin and Hematocrit Levels', 'armGroupLabels': ['Anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Friedrich Boettner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Associate Professor of Orthopaedic Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital for Special Surgery, New York', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}