Efficacy of Angiographic Embolization vs Non-embolization of Moderate/Poor Vascularized Vertebral Metastases on Intraoperative Bleeding During Surgery Decompression and Vertebral Stabilization.

Not Applicable

Recruiting

• Conditions: Early Goal Directed Therapy; Embolization, Therapeutic; Spine Metastasis; Blood Loss

• Registration Number: NCT03853434
• Lead Sponsor: Istituto Ortopedico Rizzoli

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-15
• Study First Submitted QC: 2019-02-22
• Study First Posted: 2019-02-25
• Study Start: 2019-03-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-28
• Primary Completion: 2028-11-30
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intraoperative blood loss	during procedure	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

Secondary Outcome Measures

Name	Time	Method
Concentration of Hemoglobin pre / post-operative	24 hours
duration of the hospitalization in ICU	during hospitalization
Correlation between primary tumor and vascularization	during angiographic procedure
incidence of complications related to transfusions;	during hospitalization
volume of transfused blood (ml)	intraoperatively
correlation between the type of primary tumor and blood losses	24 hours
technical evaluation of the final result of embolization (total - 100%, subtotal 90-80% and partial 70-50%) in relation to blood losses	during angiographic procedure
evaluation of operative time, from incision to end of suture	during procedure

Trial Locations

Locations (1)

Giancarlo Facchini; 🇮🇹 Bologna, Italy