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

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

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.

Study Overview

• Status: Terminated
• Conditions: Blood Loss; Spine Metastasis; Embolization, Therapeutic; Early Goal Directed Therapy
• Intervention / Treatment: Procedure: Embolization

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40136
    • Giancarlo Facchini

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Embolization; After angiography all metastases with poor/moderate vascularization will be embolized with acrylic glue in the treatment group.	Procedure: Embolization; Angiographic embolization
No Intervention: No embolization; After angiography all metastasis with poor/moderate vascularization will not be embolized with acrylic glue in the control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative blood loss	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	during procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Concentration of Hemoglobin pre / post-operative	24 hours
volume of transfused blood (ml)	intraoperatively
Correlation between primary tumor and vascularization	during angiographic procedure
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
incidence of complications related to transfusions;	during hospitalization
duration of the hospitalization in ICU	during hospitalization

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): August 30, 2025
• Study Completion (Actual): August 30, 2025

Study Registration Dates

• First Submitted: January 15, 2019
• First Submitted That Met QC Criteria: February 22, 2019
• First Posted (Actual): February 25, 2019

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 20, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: blood loss; embolization; spine metastasis; Early Goal Directed Therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hemorrhage; Therapeutics; Hemostatic Techniques; Therapeutic Occlusion; Embolization, Therapeutic
• Other Study ID Numbers: Embart

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No