Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2026-02-18 @ 1:20 AM
Study NCT ID:
NCT01798550
Status:
COMPLETED
Last Update Posted:
2017-12-14
First Post:
2013-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Enoxaparin Dosing in Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017984', 'term': 'Enoxaparin'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ckempto@emory.edu', 'phone': '404-778-1900', 'title': 'Christine Kempton MD, MSc', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 years, duration of the study', 'eventGroups': [{'id': 'EG000', 'title': 'Reduced Dose (0.8 mg/kg)', 'description': 'Enoxaparin 0.8 mg/kg (using total body weight) twice daily\n\nEnoxaparin: Twice daily dosing', 'otherNumAtRisk': 30, 'deathsNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard Dose (1 mg/kg)', 'description': 'Enoxaparin 1 mg/kg (using total body weight) twice daily\n\nEnoxaparin: Twice daily dosing', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Proportion of Patients With an Initial Therapeutic Anti-Xa Level at Steady State in Each Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reduced Dose (0.8 mg/kg)', 'description': 'Enoxaparin 0.8 mg/kg (using total body weight) twice daily\n\nEnoxaparin: Twice daily dosing'}, {'id': 'OG001', 'title': 'Standard Dose (1 mg/kg)', 'description': 'Enoxaparin 1 mg/kg (using total body weight) twice daily\n\nEnoxaparin: Twice daily dosing'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3-5 hours after at least 3rd dose', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Therapeutic Anti-Xa Level for Both Groups', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reduced Dose (0.8 mg/kg)', 'description': 'Enoxaparin 0.8 mg/kg (using total body weight) twice daily\n\nEnoxaparin: Twice daily dosing'}, {'id': 'OG001', 'title': 'Standard Dose (1 mg/kg)', 'description': 'Enoxaparin 1 mg/kg (using total body weight) twice daily\n\nEnoxaparin: Twice daily dosing'}], 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'groupId': 'OG000', 'lowerLimit': '26.7', 'upperLimit': '41.0'}, {'value': '31.9', 'groupId': 'OG001', 'lowerLimit': '27.7', 'upperLimit': '39.2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days', 'description': 'Time to therapeutic Anti-Xa = time in hours from enoxaparin dose #1 to the first therapeutic Anti-Xa. The Anti-Xa was assessed 3-5 hours after at least three consecutive enoxaparin doses. If a dose adjustment was needed, the anti-Xa level was drawn four hours after the adjusted dose of enoxaparin was administered. Dose adjustments were made until a therapeutic level within goal range was obtained.', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Median Steady State Anti-Xa Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reduced Dose (0.8 mg/kg)', 'description': 'Enoxaparin 0.8 mg/kg (using total body weight) twice daily\n\nEnoxaparin: Twice daily dosing'}, {'id': 'OG001', 'title': 'Standard Dose (1 mg/kg)', 'description': 'Enoxaparin 1 mg/kg (using total body weight) twice daily\n\nEnoxaparin: Twice daily dosing'}], 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000', 'lowerLimit': '0.66', 'upperLimit': '0.90'}, {'value': '0.86', 'groupId': 'OG001', 'lowerLimit': '0.69', 'upperLimit': '1.01'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days', 'description': 'The goal anti-Xa peak level range was defined as 0.5 - 1.1 International units/mL. The Anti-Xa was assessed 3-5 hours after at least three consecutive enoxaparin doses. If a dose adjustment was needed, the anti-Xa level was drawn four hours after the adjusted dose of enoxaparin was administered. Dose adjustments were made until a therapeutic level within goal range was obtained.', 'unitOfMeasure': 'IU/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Patients Requiring Dose Adjustments to Achieve Therapeutic Anti-Xa Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reduced Dose (0.8 mg/kg)', 'description': 'Enoxaparin 0.8 mg/kg (using total body weight) twice daily\n\nEnoxaparin: Twice daily dosing'}, {'id': 'OG001', 'title': 'Standard Dose (1 mg/kg)', 'description': 'Enoxaparin 1 mg/kg (using total body weight) twice daily\n\nEnoxaparin: Twice daily dosing'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Proportion of Patients With Major and Minor Bleeding Events Prior to Achieving a Therapeutic Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Reduced Dose (0.8 mg/kg)', 'description': 'Enoxaparin 0.8 mg/kg (using total body weight) twice daily\n\nEnoxaparin: Twice daily dosing'}, {'id': 'OG001', 'title': 'Standard Dose (1 mg/kg)', 'description': 'Enoxaparin 1 mg/kg (using total body weight) twice daily\n\nEnoxaparin: Twice daily dosing'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Hemoglobin and platelets were assessed at baseline and daily as indicated while on study up to 30 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Reduced Dose (0.8 mg/kg)', 'description': 'Enoxaparin 0.8 mg/kg (using total body weight) twice daily\n\nEnoxaparin: Twice daily dosing'}, {'id': 'FG001', 'title': 'Standard Dose (1 mg/kg)', 'description': 'Enoxaparin 1 mg/kg (using total body weight) twice daily\n\nEnoxaparin: Twice daily dosing'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Reduced Dose (0.8 mg/kg)', 'description': 'Enoxaparin 0.8 mg/kg (using total body weight) twice daily\n\nEnoxaparin: Twice daily dosing'}, {'id': 'BG001', 'title': 'Standard Dose (1 mg/kg)', 'description': 'Enoxaparin 1 mg/kg (using total body weight) twice daily\n\nEnoxaparin: Twice daily dosing'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000', 'lowerLimit': '45', 'upperLimit': '62'}, {'value': '56', 'groupId': 'BG001', 'lowerLimit': '46', 'upperLimit': '63'}, {'value': '56', 'groupId': 'BG002', 'lowerLimit': '45', 'upperLimit': '63'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '62', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2012-11-27', 'size': 332606, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2017-11-15T16:22', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2016-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-16', 'studyFirstSubmitDate': '2013-02-22', 'resultsFirstSubmitDate': '2017-10-07', 'studyFirstSubmitQcDate': '2013-02-25', 'lastUpdatePostDateStruct': {'date': '2017-12-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-10-07', 'studyFirstPostDateStruct': {'date': '2013-02-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Median Steady State Anti-Xa Levels', 'timeFrame': 'Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days', 'description': 'The goal anti-Xa peak level range was defined as 0.5 - 1.1 International units/mL. The Anti-Xa was assessed 3-5 hours after at least three consecutive enoxaparin doses. If a dose adjustment was needed, the anti-Xa level was drawn four hours after the adjusted dose of enoxaparin was administered. Dose adjustments were made until a therapeutic level within goal range was obtained.'}, {'measure': 'Number of Patients Requiring Dose Adjustments to Achieve Therapeutic Anti-Xa Level', 'timeFrame': 'Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days'}, {'measure': 'Proportion of Patients With Major and Minor Bleeding Events Prior to Achieving a Therapeutic Level', 'timeFrame': 'Hemoglobin and platelets were assessed at baseline and daily as indicated while on study up to 30 days'}], 'primaryOutcomes': [{'measure': 'Proportion of Patients With an Initial Therapeutic Anti-Xa Level at Steady State in Each Group', 'timeFrame': '3-5 hours after at least 3rd dose'}], 'secondaryOutcomes': [{'measure': 'Time to Therapeutic Anti-Xa Level for Both Groups', 'timeFrame': 'Assessed once after 3 consecutive enoxaparin doses (approx. 36 hours) and then daily if dose adjustments were indicated up to 30 days', 'description': 'Time to therapeutic Anti-Xa = time in hours from enoxaparin dose #1 to the first therapeutic Anti-Xa. The Anti-Xa was assessed 3-5 hours after at least three consecutive enoxaparin doses. If a dose adjustment was needed, the anti-Xa level was drawn four hours after the adjusted dose of enoxaparin was administered. Dose adjustments were made until a therapeutic level within goal range was obtained.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Enoxaparin dosing', 'Obesity'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine an effective enoxaparin dosing strategy in medically ill, morbidly obese patients. This study will include adult patients greater than 18 yrs of age being admitted to Grady Hospital in Atlanta, GA. Potentially vulnerable patients such as prisoners, children, and pregnant women will not be enrolled in the study. Study participants will be contacted in person by the study personnel once inclusion criteria are met. Written informed consent will be obtained in person while hospitalized. Once the patient is consented they will be given enoxaparin and blood samples will be drawn. The data collected will be from the electronic medical record which is accessed only with a username and password so it is not publicly available. The data will be identifiable upon collection and will be kept on a password protected file on a computer in a locked office. The data will be de-identified after data analysis and only the study personnel will have access to the code that links identifiers to subjects. A HIPAA waiver will be requested to access existing data in order to identify patients for enrollment. All data will be collected in an office in the hospital. The study participants' burden will be minimal and dependent only on time of consent process since morbidly obese patients would be receiving this blood sample collection regardless of their participation in the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planned treating with twice daily enoxaparin\n* BMI \\>= 40 kg/m2\n\nExclusion Criteria:\n\n* \\< 18 years of age\n* CrCl \\< 30 ml/min\n* Pregnancy\n* Prisoner\n* Active bleeding\n* Already received 3 consecutive doses of enoxaparin\n* Use of therapeutic enoxaparin for more than 5 consecutive days within the last 3 months'}, 'identificationModule': {'nctId': 'NCT01798550', 'briefTitle': 'Enoxaparin Dosing in Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Evaluation of Enoxaparin Dosing in Hospitalized Morbidly Obese Patients at an Academic Medical Center', 'orgStudyIdInfo': {'id': 'IRB00063210'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reduced Dose (0.8 mg/kg)', 'description': 'Enoxaparin 0.8 mg/kg (using total body weight) twice daily', 'interventionNames': ['Drug: Enoxaparin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Dose (1 mg/kg)', 'description': 'Enoxaparin 1 mg/kg (using total body weight) twice daily', 'interventionNames': ['Drug: Enoxaparin']}], 'interventions': [{'name': 'Enoxaparin', 'type': 'DRUG', 'otherNames': ['Lovenox'], 'description': 'Twice daily dosing', 'armGroupLabels': ['Reduced Dose (0.8 mg/kg)', 'Standard Dose (1 mg/kg)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Grady Memorial Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Christine L Kempton, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Department of Pediatrics and Department of Hematology and Medical Oncology', 'investigatorFullName': 'Christine Kempton, MD, MSc', 'investigatorAffiliation': 'Emory University'}}}}