Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2025-12-26 @ 11:13 PM
Study NCT ID:
NCT05706012
Status:
COMPLETED
Last Update Posted:
2024-05-09
First Post:
2023-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Antithrombotic Management of Acute Mesenteric Ischaemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012778', 'term': 'Short Bowel Syndrome'}], 'ancestors': [{'id': 'D008286', 'term': 'Malabsorption Syndromes'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2023-01-20', 'studyFirstSubmitQcDate': '2023-01-20', 'lastUpdatePostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Type of antithrombotic therapy', 'timeFrame': 'April 2023', 'description': 'Overview of the type of long-term antithrombotic therapy that is prescribed in SBS patients with AMI, depending on the anatomy of the gastrointestinal tract, the aetiology of AMI and whether or not revascularisation of the occluding blood vessel has been performed'}], 'secondaryOutcomes': [{'measure': 'Duration of antithrombotic therapy', 'timeFrame': 'April 2023', 'description': 'Overview of the duration of long-term antithrombotic therapy in SBS patients with AMI depending on the anatomy of the gastrointestinal tract, the aetiology of AMI and whether or not revascularisation of the occluding blood vessel has been performed.'}, {'measure': 'Initial dose of antithrombotic therapy', 'timeFrame': 'April 2023', 'description': 'Overview of the initial dose of long-term antithrombotic therapy in SBS patients with AMI depending on the anatomy of the gastrointestinal tract, the aetiology of AMI and whether or not revascularisation of the occluding blood vessel has been performed.'}, {'measure': 'Dose adjustments of antithrombotic therapy', 'timeFrame': 'April 2023', 'description': 'Overview of any dose adjustments of long-term antithrombotic therapy in SBS patients with AMI depending on the anatomy of the gastrointestinal tract, the aetiology of AMI and whether or not revascularisation of the occluding blood vessel has been performed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Mesenteric Ischemia', 'Short Bowel Syndrome']}, 'descriptionModule': {'briefSummary': 'Guidelines on the acute and long-term pharmacological treatment of acute mesenteric ischaemia (AMI) recommend the use of thrombolytic, antiplatelet or anticoagulant therapy depending on the aetiology of AMI and the use of stenting but only few details are given on the choice of the drug, dose and duration of treatment. Besides, recommendations are mainly based on data on coronary, cerebral and other peripheral artery diseases and do also not take into account the altered drug absorption in patients with short bowel syndrome, in which AMI can result.This case-based survey will inform us on the current international clinical practice of long-term antithrombotic management of AMI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'international gastro-enterologists an cardiologists', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* gastro-enterologist or cardiologist with expertise in treating SBS patients resulting from AMI\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT05706012', 'briefTitle': 'Antithrombotic Management of Acute Mesenteric Ischaemia', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Long-term Antithrombotic Management of Acute Mesenteric Ischaemia: Case-based Survey', 'orgStudyIdInfo': {'id': 's67503'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Gastro-enterologists and anticoagulation specialists', 'description': 'An online survey will be sent to question current clinical practice in long-term antithrombotic management of AMI in SBS patients.', 'interventionNames': ['Other: Survey']}], 'interventions': [{'name': 'Survey', 'type': 'OTHER', 'description': 'Online survey questioning the current clinical practice on long-term antithrombotic management of AMI in SBS patients', 'armGroupLabels': ['Gastro-enterologists and anticoagulation specialists']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'no IPD will be shared with other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}