Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT05058469
Status:
RECRUITING
Last Update Posted:
2024-07-31
First Post:
2021-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Tracheotomy With and Without Dual Antiplatelet Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014140', 'term': 'Tracheotomy'}], 'ancestors': [{'id': 'D013517', 'term': 'Otorhinolaryngologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019616', 'term': 'Thoracic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-30', 'studyFirstSubmitDate': '2021-09-14', 'studyFirstSubmitQcDate': '2021-09-23', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of bleeding during Percutaneous Dilational Tracheostomy (PDT) with and without antiplatelet therapy (AP).', 'timeFrame': '3 days', 'description': '* bleeding (yes/no)\n* intervention (yes/no)\n* decrease (\\>= 1 g/dl) of hemoglobin (yes/no)\n* number of blood transfusion(s)'}], 'secondaryOutcomes': [{'measure': '- Does the technique of PDT affect the bleeding rate? - How often are recognizable cartilage pin fractures in the context of a PDT? - Influence of AP and PDT technology on the frequency of need for a blood transfusion?', 'timeFrame': '14 days', 'description': 'cartilage pin fractures seen in endoscopy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tracheostomy Hemorrhage']}, 'descriptionModule': {'briefSummary': 'Platelet-inhibiting drugs are often used after vascular interventions. Patients who require such therapies are often critically ill, are treated in intensive care units and often require long-term ventilation. For long-term ventilation a tracheotomy is necessary, which is usually performed as a percutaneous dilatative tracheotomy (PDT). As part of this intervention, there is (theoretically) an increased risk of bleeding/an increased rate of complications in patients with a antiplatelet therapy. In addition, there are various techniques for performing a PDT.\n\nThe current study aims to investigate the frequency of bleeding/complications taking into account the technique used in PDT.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent Percutaneous Dilational Tracheostomy within the last 5 years.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who underwent Percutaneous Dilational Tracheostomy\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT05058469', 'acronym': 'PDT and (D)APT', 'briefTitle': 'Tracheotomy With and Without Dual Antiplatelet Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Asklepios Neurological Clinic Bad Salzhausen'}, 'officialTitle': 'Evaluation of the Safety of Percutaneous Tracheotomies in Intensive Care Patients With and Without Antiplatelet Therapy and Comparison of Two Tracheotomy Techniques', 'orgStudyIdInfo': {'id': 'PDT and (D)APT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tracheotomy without antiplatelet therapy+technique 1', 'interventionNames': ['Device: Tracheotomy']}, {'label': 'Tracheotomy under antiplatelet therapy+technique 1', 'interventionNames': ['Device: Tracheotomy']}, {'label': 'Tracheotomy without antiplatelet therapy+technique 2', 'interventionNames': ['Device: Tracheotomy']}, {'label': 'Tracheotomy under antiplatelet therapy+technique 2', 'interventionNames': ['Device: Tracheotomy']}], 'interventions': [{'name': 'Tracheotomy', 'type': 'DEVICE', 'description': 'Tracheotomy in patients +/- antiplatelet therapy', 'armGroupLabels': ['Tracheotomy under antiplatelet therapy+technique 1', 'Tracheotomy under antiplatelet therapy+technique 2', 'Tracheotomy without antiplatelet therapy+technique 1', 'Tracheotomy without antiplatelet therapy+technique 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63667', 'city': 'Nidda', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Dirk Bandorski, MD', 'role': 'CONTACT', 'email': 'd.bandorski@asklepios.com', 'phone': '+496043804212'}, {'name': 'Jens Allendörfer, MD', 'role': 'CONTACT'}], 'facility': 'Neurologische Klinik Bad Salzhausen', 'geoPoint': {'lat': 50.4133, 'lon': 9.00638}}], 'centralContacts': [{'name': 'Dirk Bandorski, MD', 'role': 'CONTACT', 'email': 'd.bandorski@asklepios.com', 'phone': '+496043804212'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asklepios Neurological Clinic Bad Salzhausen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}