Status:
RECRUITING
Efficacy of Angiographic Embolization vs Non-embolization of Moderate/Poor Vascularized Vertebral Metastases on Intraoperative Bleeding During Surgery Decompression and Vertebral Stabilization.
Lead Sponsor:
Istituto Ortopedico Rizzoli
Conditions:
Spine Metastasis
Early Goal Directed Therapy
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- Male, Female aged 18 years and 75 years
- prognosis \>6 months (Tokuhashi score ≤ 11)
- patients with lesions with moderate vascularization (grade 2)
- time between embolization and intervention \>/= 48-72 h
Exclusion
- 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);
- renal failure (creatinine ≥ 1.2);
- MDC iodized allergy;
- pregnancy / lactation;
- chronic ischemic heart disease;
- precluded arterial access by angiography;
- indication to emergency surgery;
- time between embolization and surgery\> 72 h;
- refusal by the patient.
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03853434
Start Date
March 1 2019
End Date
December 31 2028
Last Update
January 28 2025
Active Locations (1)
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1
Giancarlo Facchini
Bologna, Italy, 40136