Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT01230658
Status:
COMPLETED
Last Update Posted:
2024-08-14
First Post:
2010-10-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prophylactic Enoxaparin Dosing in Roux-en-Y Gastric Bypass Surgery Patients at St. Vincent Carmel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-13', 'studyFirstSubmitDate': '2010-10-28', 'studyFirstSubmitQcDate': '2010-10-28', 'lastUpdatePostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anti-factor Xa concentrations from patients 18 years or older undergoing primary Roux-en-Y gastric bypass surgery at St. Vincent Carmel Bariatric Center of Excellence', 'timeFrame': 'Anti-factor Xa concentrations obtained at steady state (3-5 hours after third enoxaparin dose)'}], 'secondaryOutcomes': [{'measure': 'Thrombotic events - DVT confirmed by doppler guided ultrasound or PE confirmed by CT scan', 'timeFrame': 'within 30 days of surgery'}, {'measure': 'Hemorrhagic events - defined as a change in hemoglobin greater than 3 G/dL, transfusion of packed red blood cells, endoscopic procedure indicating GI bleeding, or other major bleeding event documented by physician.', 'timeFrame': 'within 30 days of surgery'}, {'measure': 'Re-admissions to a hospital within 30 days of surgery due to thrombotic or hemorrhagic event', 'timeFrame': 'within 30 days of surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['prophylactic enoxaparin', 'Roux en Y gastric bypass surgery'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess anti-factor Xa concentrations in patients given prophylactic enoxaparin after bariatric surgery.', 'detailedDescription': "FDA-approved enoxaparin dosing for venous thromboembolism (VTE) prophylaxis is a fixed-dose regimen irrespective of body mass index (BMI) or actual body weight (ABW). Clinical trials suggest that dosing may be inadequate for obese patients. We plan to assess anti-factor-Xa concentrations in patients who received prophylactic enoxaparin after bariatric surgery.\n\nThis prospective study will examine 150 anti-factor Xa concentrations from patients 18 years or older undergoing primary Roux-en-Y gastric bypass surgery at St. Vincent Carmel Bariatric Center of Excellence. Patients receive varying prophylactic enoxaparin regimens at the surgeon's discretion. Anti-factor-Xa concentrations are obtained at steady state."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients 18 years or older undergoing primary roux-en-Y gastric bypass surgery at St. Vincent Carmel Bariatric Center of Excellence.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 years and older undergoing primary roux-en-Y gastric bypass surgery at St. Vincent Carmel Bariatric Center of Excellence\n\nExclusion Criteria:\n\n* Receiving anticoagulation therapy prior to surgery (i.e. warfarin)\n* Did not receive enoxaparin after surgery'}, 'identificationModule': {'nctId': 'NCT01230658', 'briefTitle': 'Prophylactic Enoxaparin Dosing in Roux-en-Y Gastric Bypass Surgery Patients at St. Vincent Carmel', 'organization': {'class': 'OTHER', 'fullName': 'Ascension St. Vincent Carmel Hospital'}, 'officialTitle': 'Prophylactic Enoxaparin Dosing in Roux-en-Y Gastric Bypass Surgery Patients at the St. Vincent Carmel Bariatric Center of Excellence', 'orgStudyIdInfo': {'id': 'STV IRB R2009-111'}}, 'contactsLocationsModule': {'locations': [{'zip': '46032', 'city': 'Carmel', 'state': 'Indiana', 'country': 'United States', 'facility': 'St. Vincent Carmel Bariatric Center of Excellence', 'geoPoint': {'lat': 39.97837, 'lon': -86.11804}}], 'overallOfficials': [{'name': 'Karen S Wall, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ascension St. Vincent Carmel Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ascension St. Vincent Carmel Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pharmacist', 'investigatorFullName': 'Karen Wall', 'investigatorAffiliation': 'Ascension St. Vincent Carmel Hospital'}}}}