Ignite Creation Date:
2025-12-24 @ 10:20 PM
Ignite Modification Date:
2025-12-25 @ 7:53 PM
Study NCT ID:
NCT04503135
Status:
COMPLETED
Last Update Posted:
2023-05-01
First Post:
2020-08-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Catheter Associated Asymptomatic Thrombosis in Intensive Care Unit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056824', 'term': 'Upper Extremity Deep Vein Thrombosis'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 203}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-10-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-28', 'studyFirstSubmitDate': '2020-08-03', 'studyFirstSubmitQcDate': '2020-08-03', 'lastUpdatePostDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients developing Catheter related thrombosis and Incidence of CRT in patients in ICU', 'timeFrame': 'Until CVC removal', 'description': 'The main objective of this study is to assess the proportion of patients developing CRT (proportion) and the incidence of CRT (rate expressed in catheter events/days) in patients in ICU.'}], 'secondaryOutcomes': [{'measure': 'Proportion of various types of thrombotic apposition', 'timeFrame': 'Until CVC removal', 'description': 'The proportion of various types of thrombotic apposition'}, {'measure': 'Deep venous thrombosis (DVT) proportion and Incidence', 'timeFrame': 'Until CVC removal', 'description': 'The proportion of patients developing DVT and the incidence of catheter-related DVT (rate) in patients in ICU carrying CVC.'}, {'measure': 'the association of thrombosis with alterations of hemocoagulative parameters', 'timeFrame': 'Until CVC removal', 'description': 'the association of thrombosis with alterations of hemocoagulative parameters'}, {'measure': 'describe the clinical measures that have been taken following the diagnosis of CRT.describe the clinical measures that have been taken following the diagnosis of CRT.', 'timeFrame': 'Until CVC removal', 'description': 'describe the clinical measures that have been taken following the diagnosis of CRT.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Central Venous Catheters', 'Central Venous Catheter Thrombosis', 'Thrombosis, Venous', 'Intensive Care Unit']}, 'referencesModule': {'references': [{'pmid': '16864670', 'type': 'BACKGROUND', 'citation': 'Forauer AR, Theoharis CG, Dasika NL. Jugular vein catheter placement: histologic features and development of catheter-related (fibrin) sheaths in a swine model. Radiology. 2006 Aug;240(2):427-34. doi: 10.1148/radiol.2402031129.'}, {'pmid': '15975139', 'type': 'BACKGROUND', 'citation': 'Rooden CJ, Tesselaar ME, Osanto S, Rosendaal FR, Huisman MV. Deep vein thrombosis associated with central venous catheters - a review. J Thromb Haemost. 2005 Nov;3(11):2409-19. doi: 10.1111/j.1538-7836.2005.01398.x. Epub 2005 Jun 24. No abstract available.'}, {'pmid': '22315267', 'type': 'BACKGROUND', 'citation': 'Bates SM, Jaeschke R, Stevens SM, Goodacre S, Wells PS, Stevenson MD, Kearon C, Schunemann HJ, Crowther M, Pauker SG, Makdissi R, Guyatt GH. Diagnosis of DVT: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e351S-e418S. doi: 10.1378/chest.11-2299.'}, {'pmid': '28839334', 'type': 'BACKGROUND', 'citation': 'Hrdy O, Strazevska E, Suk P, Vach R, Karlik R, Jarkovsky J, Sas I, Gal R. Central venous catheter-related thrombosis in intensive care patients - incidence and risk factors: A prospective observational study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2017 Dec;161(4):369-373. doi: 10.5507/bp.2017.034. Epub 2017 Aug 24.'}, {'pmid': '31406439', 'type': 'BACKGROUND', 'citation': 'Nm Bhat M, Venkataraman R, Ramakrishnan N, K Abraham B, Rajagopalan S. Value of Routine Sonographic Screening of Internal Jugular Vein to Detect Catheter Related Thrombosis in Intensive Care Unit. Indian J Crit Care Med. 2019 Jul;23(7):326-328. doi: 10.5005/jp-journals-10071-23207.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to describe the incidence of catheter-related and non-catheter-related thrombosis in a population of adults in ICU and to assess its correlation with alteration of coagulation parameters.', 'detailedDescription': 'Central venous catheter (CVC) is now indispensable in the monitoring and care of patients in intensive care (ICU). Unfortunately, one of the complications of its positioning is catheter-related thrombosis (CRT) and its consequences. Despite the widespread use of CVC and the extensive literature describing its complications, areas of uncertainty regarding the onset, treatment and prevention of CRT persist, especially with regard to asymptomatic thrombosis.\n\nThis study aims to describe the incidence of catheter-related and non-catheter-related thrombosis in a population of adults in ICU and to assess its correlation with alteration of coagulation parameters.\n\nThe main objective of this study is to assess the proportion of patients developing CRT (proportion) and the incidence of CRT (rate expressed in catheter events/days) in patients in ICU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Intensive Care Unit (ICU) adult patients requiring Central venous catheter for clinical reasons', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients over the age of 18\n* admitted to intensive care who have for clinical reasons need to place a central venous catheter\n* signing of informed consent\n\nExclusion Criteria:\n\n* patients under 18 years of age\n* Known cancer status\n* Congenital thrombophilia'}, 'identificationModule': {'nctId': 'NCT04503135', 'acronym': 'CAAT', 'briefTitle': 'Catheter Associated Asymptomatic Thrombosis in Intensive Care Unit', 'organization': {'class': 'OTHER', 'fullName': 'Policlinico Hospital'}, 'officialTitle': 'Prospective Cohort Study on Catheter Associated Asymptomatic Thrombosis in Intensive Care Unit', 'orgStudyIdInfo': {'id': '172_2020'}}, 'armsInterventionsModule': {'interventions': [{'name': 'ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'ultrasound of the central veins of the neck and chest and a (compression ultra-sound) CUS of the femoral veins will be performed bilaterally'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20122', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': "Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico", 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}], 'overallOfficials': [{'name': 'chiara Abbruzzese, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Policlinico Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mauro Panigada', 'investigatorAffiliation': 'Policlinico Hospital'}}}}