Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2026-02-18 @ 1:40 AM
Study NCT ID:
NCT01665495
Status:
UNKNOWN
Last Update Posted:
2012-08-15
First Post:
2012-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drainage or Pericardiocentesis (DROP) Alone for Recurrent Non-malignant Pericardial Effusions Requiring Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010490', 'term': 'Pericardial Effusion'}, {'id': 'D002305', 'term': 'Cardiac Tamponade'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 122}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2014-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-08-14', 'studyFirstSubmitDate': '2012-08-12', 'studyFirstSubmitQcDate': '2012-08-14', 'lastUpdatePostDateStruct': {'date': '2012-08-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Complication rates', 'timeFrame': '12 months', 'description': 'Major complications: fatal, life-threatening or requiring any intervention Minor complications: any requiring only monitoring or follow-up'}], 'primaryOutcomes': [{'measure': 'Recurrent pericardial effusion', 'timeFrame': '12 months'}, {'measure': 'Need for repeated pericardiocentesis', 'timeFrame': '12 months'}, {'measure': 'Need for cardiac surgery', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Hospital stay', 'timeFrame': '12 months'}, {'measure': 'Disease-related hospitalization', 'timeFrame': '12 months'}, {'measure': 'Overall mortality', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pericardial effusion', 'cardiac tamponade', 'pericardiocentesis', 'pericardial drainage', 'prevention'], 'conditions': ['Pericardial Effusion']}, 'referencesModule': {'references': [{'pmid': '23867908', 'type': 'DERIVED', 'citation': 'Imazio M, Belli R, Beqaraj F, Giammaria M, Lestuzzi C, Hoit B, LeWinter M, Spodick DH, Adler Y; DROP Investigators. DRainage Or Pericardiocentesis alone for recurrent nonmalignant, nonbacterial pericardial effusions requiring intervention: rationale and design of the DROP trial, a randomized, open-label, multicenter study. J Cardiovasc Med (Hagerstown). 2014 Jun;15(6):510-4. doi: 10.2459/JCM.0b013e3283621d26.'}]}, 'descriptionModule': {'briefSummary': 'The DROP study is a prospective, multi center, randomized, open-label trial to test the efficacy and safety of extended catheter pericardial drainage in patients with non-malignant pericardial effusions.', 'detailedDescription': 'The trial will compared the efficacy and safety of pericardiocentesis alone compared with extended pericardial catheter drainage for the prevention of recurrent effusions in patients with non-malignant pericardial effusions requiring intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients\n* pericardial effusion requiring pericardiocentesis\n* non-malignant etiology\n\nExclusion Criteria:\n\n* known neoplastic etiology\n* known bacterial etiology'}, 'identificationModule': {'nctId': 'NCT01665495', 'acronym': 'DROP', 'briefTitle': 'Drainage or Pericardiocentesis (DROP) Alone for Recurrent Non-malignant Pericardial Effusions Requiring Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Maria Vittoria Hospital'}, 'officialTitle': 'Drainage or Pericardiocentesis Alone for Recurrent Non-malignant Pericardial Effusions Requiring Intervention.', 'orgStudyIdInfo': {'id': '72/16/11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Pericardiocentesis', 'description': 'Pericardial fluid drained by simple echo-guided pericardiocentesis'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Extended pericardial drainage', 'description': 'Extended pericardial drainage will include pericardiocentesis followed by an intermittent pericardial catheter drainage. Pericardial drainage will be kept till daily fluid return\\<30ml', 'interventionNames': ['Procedure: Extended pericardial drainage by catheter']}], 'interventions': [{'name': 'Extended pericardial drainage by catheter', 'type': 'PROCEDURE', 'description': 'Extended pericardial drainage will be done after pericardiocentesis by the insertion of a catheter to intermittently drain pericardial fluid till daily fluid return\\<30 ml.', 'armGroupLabels': ['Extended pericardial drainage']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bergamo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonio Brucato, MD', 'role': 'CONTACT'}, {'name': 'Antonio Brucato, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedali Riuniti', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'city': 'Bolzano', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Italy', 'facility': 'Ospedale Regionale San Maurizio', 'geoPoint': {'lat': 46.49067, 'lon': 11.33982}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Anna Gandino, MD', 'role': 'CONTACT'}, {'name': 'Anna Gandino, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Niguarda', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Rivoli', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Italy', 'facility': 'Ospedale degli Infermi', 'geoPoint': {'lat': 45.07073, 'lon': 7.51465}}, {'city': 'Torino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Massimo Imazio, MD,FESC', 'role': 'CONTACT', 'phone': '+39 0114393391'}, {'name': 'Massimo Imazio, MD FESC', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Riccardo Belli, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Massimo Giammaria, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Federico Beqeraj, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cardiology Department, Maria Vittoria Hospital', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Torino', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Massimo Minelli, MD', 'role': 'CONTACT'}, {'name': 'Massimo Minelli, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cardiology Department, Ospedale San Giovanni Bosco', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'city': 'Torino', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Italy', 'facility': 'Ospedale Mauriziano', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}], 'centralContacts': [{'name': 'Massimo Imazio, MD FESC', 'role': 'CONTACT', 'email': 'massimo_imazio@yahoo.it', 'phone': '+390114393391'}, {'name': 'Riccardo Belli, MD FESC', 'role': 'CONTACT', 'phone': '+390114393557'}], 'overallOfficials': [{'name': 'Massimo Imazio, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cardiology Department, Maria Vittoria Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maria Vittoria Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiologist', 'investigatorFullName': 'Massimo Imazio', 'investigatorAffiliation': 'Maria Vittoria Hospital'}}}}