Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-01-06 @ 8:37 PM
Study NCT ID:
NCT03853434
Status:
RECRUITING
Last Update Posted:
2025-01-28
First Post:
2019-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Angiographic Embolization vs Non-embolization of Moderate/Poor Vascularized Vertebral Metastases on Intraoperative Bleeding During Surgery Decompression and Vertebral Stabilization.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004621', 'term': 'Embolization, Therapeutic'}], 'ancestors': [{'id': 'D006489', 'term': 'Hemostatic Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D060205', 'term': 'Therapeutic Occlusion'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-24', 'studyFirstSubmitDate': '2019-01-15', 'studyFirstSubmitQcDate': '2019-02-22', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative blood loss', 'timeFrame': 'during procedure', 'description': 'volume (ml) of intraoperative blood loss volume aspirated from operative field (ml) + differential weight gauze at the end of surgery - dry gauze weight with 1g blood conversion = 0.948ml'}], 'secondaryOutcomes': [{'measure': 'Concentration of Hemoglobin pre / post-operative', 'timeFrame': '24 hours'}, {'measure': 'volume of transfused blood (ml)', 'timeFrame': 'intraoperatively'}, {'measure': 'Correlation between primary tumor and vascularization', 'timeFrame': 'during angiographic procedure'}, {'measure': 'correlation between the type of primary tumor and blood losses', 'timeFrame': '24 hours'}, {'measure': 'technical evaluation of the final result of embolization (total - 100%, subtotal 90-80% and partial 70-50%) in relation to blood losses', 'timeFrame': 'during angiographic procedure'}, {'measure': 'evaluation of operative time, from incision to end of suture', 'timeFrame': 'during procedure'}, {'measure': 'incidence of complications related to transfusions;', 'timeFrame': 'during hospitalization'}, {'measure': 'duration of the hospitalization in ICU', 'timeFrame': 'during hospitalization'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['embolization', 'blood loss', 'Early Goal Directed Therapy', 'spine metastasis'], 'conditions': ['Spine Metastasis', 'Early Goal Directed Therapy', 'Embolization, Therapeutic', 'Blood Loss']}, 'descriptionModule': {'briefSummary': 'Although angiographic embolization has been introduced for preoperative management of spine metastases in 1975 and is suggested today by many authors in the management of such pathologies, it needs to be confirmed by RCT. It is a minimally invasive procedure, not free from complications. The recent meta-analyzes, due to the limited number of patients included are not exhaustive about the effectiveness of embolization in the reduction of the intraoperative bleeding, especially in the context of poor / moderate metastasis vascularization. We want to evaluate the efficacy of preoperative angiographic embolization of intermediate / poor vascularized spine metastases in reducing intraoperative blood loss during excision surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male, Female aged 18 years and 75 years\n* prognosis \\>6 months (Tokuhashi score ≤ 11)\n* patients with lesions with moderate vascularization (grade 2)\n* time between embolization and intervention \\>/= 48-72 h\n\nExclusion Criteria:\n\n* congenital and iatrogenic hemocoagulative disorders (PT INR\\> 1.5, aPTT ratio\\> 1.25 with documented coagulation factor deficiency, PLT \\< 80,000 / microL or known coagulation pathologies);\n* renal failure (creatinine ≥ 1.2);\n* MDC iodized allergy;\n* pregnancy / lactation;\n* chronic ischemic heart disease;\n* precluded arterial access by angiography;\n* indication to emergency surgery;\n* time between embolization and surgery\\> 72 h;\n* refusal by the patient.'}, 'identificationModule': {'nctId': 'NCT03853434', 'acronym': 'Embart', 'briefTitle': 'Efficacy of Angiographic Embolization vs Non-embolization of Moderate/Poor Vascularized Vertebral Metastases on Intraoperative Bleeding During Surgery Decompression and Vertebral Stabilization.', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Ortopedico Rizzoli'}, 'officialTitle': 'Efficacy of Angiographic Embolization vs Non-embolization of Moderate/Poor Vascularized Vertebral Metastases on Intraoperative Bleeding During Surgery Decompression and Vertebral Stabilization. Randomized Controlled Observer- Blinded', 'orgStudyIdInfo': {'id': 'Embart'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Embolization', 'description': 'After angiography all metastases with poor/moderate vascularization will be embolized with acrylic glue in the treatment group.', 'interventionNames': ['Procedure: Embolization']}, {'type': 'NO_INTERVENTION', 'label': 'No embolization', 'description': 'After angiography all metastasis with poor/moderate vascularization will not be embolized with acrylic glue in the control group'}], 'interventions': [{'name': 'Embolization', 'type': 'PROCEDURE', 'description': 'Angiographic embolization', 'armGroupLabels': ['Embolization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40136', 'city': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giancarlo Facchini', 'role': 'CONTACT', 'email': 'giancarlo.facchini@gmail.com', 'phone': '3336500944'}], 'facility': 'Giancarlo Facchini', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'centralContacts': [{'name': 'Giancarlo Facchini', 'role': 'CONTACT', 'email': 'giancarlo.facchini@ior.it', 'phone': '3336500944'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Ortopedico Rizzoli', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}