Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT04216394
Status:
COMPLETED
Last Update Posted:
2024-03-27
First Post:
2019-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anticoagulation in Emergency General Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-26', 'studyFirstSubmitDate': '2019-11-27', 'studyFirstSubmitQcDate': '2019-12-30', 'lastUpdatePostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of operative', 'timeFrame': 'Oct 2019 - Aug 2021', 'description': 'To determine the bleeding risk and need for unplanned intervention'}, {'measure': 'Number of Participants with interventional radiology', 'timeFrame': 'Oct 2019 - Aug 2021', 'description': 'To determine the bleeding risk and need for unplanned intervention'}, {'measure': 'Number of Participants with ultrasound aspiration', 'timeFrame': 'Oct 2019 - Aug 2021', 'description': 'To determine the bleeding risk and need for unplanned intervention'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Emergency General Surgery']}, 'descriptionModule': {'briefSummary': 'While DOACs are increasing in use in the EGS patient population, the risk of bleeding and the reversal of these agents to reduce hemorrhage is still evolving. Given the paucity of data regarding the impact of DOACs in this patient population, it becomes empiric to identify bleeding patterns and outcomes in the EGS population taking DOACs. We hypothesize that patients taking a DOAC will have a higher bleeding incidence and need for an unplanned intervention secondary to hemorrhage in EGS patients undergoing an urgent or emergent operation when compared to patients taking warfarin and antiplatelets.', 'detailedDescription': 'Emergency general surgery (EGS) represents illnesses of diverse pathology with urgent/emergent treatment needs being the common denominator.A characteristic feature of EGS is its limitation in patient preparation. It is difficult and often impossible to eliminate certain patient dependent factors to reduce the operative risk. It has been reported that the annual case rate in the EGS population is (1,290 per 100,000) higher than the sum of all cancer diagnoses. The EGS burden is substantial and continues to increase. The elderly patient population represents 48% of the overall EGS population. With the increase in the prevalence of atherosclerotic disease in the elderly there has been an increase in the use of antiplatelets and anticoagulants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Emergency general surgery patient population taking Direct oral anticoagulants', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients who are confirmed to be taking dabigatran, rivaroxaban, apixaban, warfarin and antiplatelet therapy (aspirin, clopidogril, ticagrelor) undergoing an urgent or emergent surgical intervention by the emergency general surgery service within 24 hours of arrival to the hospital\n* 18 years of age or over\n\nExclusion Criteria:\n\n* Prisoners\n* Pregnant patients\n* Those who received an index operation at an outside facility and were transferred\n* Under 18 years of age'}, 'identificationModule': {'nctId': 'NCT04216394', 'briefTitle': 'Anticoagulation in Emergency General Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Methodist Health System'}, 'officialTitle': 'Anticoagulation in Emergency General Surgery: Who Bleeds More? The ACES Trial', 'orgStudyIdInfo': {'id': '049.GME.2019.D'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Emergency general surgery', 'type': 'PROCEDURE', 'description': 'multidisciplinary surgery performed for traumatic and non-traumatic acute conditions during the same admission in the hospital.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75203', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Methodist Dallas Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Michael Truitt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Methodist Dallas Medical Center Trauma'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Methodist Health System', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}