Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-28 @ 9:25 AM
Study NCT ID:
NCT06262750
Status:
RECRUITING
Last Update Posted:
2024-02-16
First Post:
2023-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Safety and Efficacy of Anticoagulation Treatment in Patients With Splanchnic Vein Thrombosis: SAPIENT Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-15', 'studyFirstSubmitDate': '2023-11-07', 'studyFirstSubmitQcDate': '2024-02-15', 'lastUpdatePostDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidenze of bleedings events', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Bleeding events will be classified according to ISTH definition, as follows:major bleedings,clinically relevant non-major bleedings (CRNMB), minor bleedings'}, {'measure': 'Incidence of venous and arterial thromboembolic events', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'All venous and arterial thromboembolic (VTE and ATE) events during the study period will be registered and counted'}, {'measure': 'Rate of progress /stable /regressive', 'timeFrame': 'every six months, up to 2 years', 'description': 'To evaluate the impact of anticoagulation therapy on SVT, all enrolled patients will undergo imaging test (doppler ultrasound, contrast-enhanced CT or MR angiography).'}, {'measure': 'incidence of liver related events', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'To evaluate the onset of liver-related events (variceal bleeding, ascites, bacterial infections, and hepatic encephalopathy), all enrolled patients will be clinically assessed'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Splanchnic Vein Thrombosis']}, 'descriptionModule': {'briefSummary': 'Prospective single-centre, observational study with medical products. Patients with a medical history of SVT will be observed for at least 24 months after inclusion. The study will begin when the patient is referred to our centre for SVT and will end at the 24-month follow-up or at the occurrence of a study outcome event, or in case of Death OBJECTIVE: To prospectively define the incidence of recurrent thrombosis and bleeding events during anticoagulant therapy in patients with diagnosed SVT, regardless of whether they will be hospitalized or treated as outpatients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive adult patients referred to the Fondazione Policlinico Universitario Agostino Gemelli IRCCS for SVT, either as inpatients or outpatients, and requiring anticoagulant therapy will be eligible for inclusion in this study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* age ≥ 18 years\n* ability to provide informed consent;\n* confirmed diagnosis of deep vein thrombosis involving splanchnic veins in liver cirrhosis (with or without hepatocarcinoma);\n* confirmed diagnosis of deep vein thrombosis involving splanchnic veins in absence of liver cirrhosis (with or without portal cavernoma);\n* pregnant patients will be eligible for inclusion in the study;\n* ongoing anticoagulant treatment with vitamin K-antagonists (VKA), direct oral anticoagulants (DOAC), low molecular weight heparin (LMWH), fondaparinux\n\nEXCLUSION CRITERIA\n\n* splanchnic vein tumor thrombosis;\n* absence of antithrombotic prophylaxis'}, 'identificationModule': {'nctId': 'NCT06262750', 'acronym': 'SAPIENT', 'briefTitle': 'Evaluation of Safety and Efficacy of Anticoagulation Treatment in Patients With Splanchnic Vein Thrombosis: SAPIENT Study', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Evaluation of Safety and Efficacy of Anticoagulation Treatment in Patients With Splanchnic Vein Thrombosis: SAPIENT Study', 'orgStudyIdInfo': {'id': '00375/23'}}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Valerio De Stefano', 'role': 'CONTACT'}, {'name': 'Rossella Talerico', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Silvia Betti', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Francesco Santopaolo', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'UOC Servizio e DH Ematologia', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'valerio de stefano', 'role': 'CONTACT', 'email': 'valerio.destefano@unicatt.it', 'phone': '+390630154206'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor', 'investigatorFullName': 'DE STEFANO VALERIO', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}