Actively Recruiting
Efficacy of Angiographic Embolization vs Non-embolization of Moderate/Poor Vascularized Vertebral Metastases on Intraoperative Bleeding During Surgery Decompression and Vertebral Stabilization.
Led by Istituto Ortopedico Rizzoli · Updated on 2025-01-28
100
Participants Needed
1
Research Sites
513 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of Angiographic Embolization vs Non-embolization of Moderate/Poor Vascularized Vertebral Metastases on Intraoperative Bleeding During Surgery Decompression and Vertebral Stabilization.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 to 75 years
- Prognosis longer than 6 months (Tokuhashi score ≤ 11)
- Lesions with moderate vascularization (grade 2)
- Time between embolization and surgery is 48 to 72 hours or more
You will not qualify if you...
- Blood clotting disorders or platelet count below 80,000/microL
- Prolonged coagulation times (PT INR > 1.5, aPTT ratio > 1.25)
- Kidney failure with creatinine ≥ 1.2
- Allergy to iodized contrast dye
- Pregnancy or breastfeeding
- Chronic ischemic heart disease
- Unable to access arteries for angiography
- Emergency surgery required
- Time between embolization and surgery greater than 72 hours
- Patient refusal to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Giancarlo Facchini
Bologna, Italy, 40136
Actively Recruiting
Research Team
G
Giancarlo Facchini
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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