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

NCT03853434 | Recruiting

• 1 other identifier: Embart
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

embolization; blood loss; Early Goal Directed Therapy; spine metastasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

Study Arms (2)

Embolization

EXPERIMENTAL

After angiography all metastases with poor/moderate vascularization will be embolized with acrylic glue in the treatment group.

Procedure: Embolization

No embolization

NO INTERVENTION

After angiography all metastasis with poor/moderate vascularization will not be embolized with acrylic glue in the control group

Interventions

Embolization PROCEDURE

Angiographic embolization

Embolization

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Giancarlo Facchini

Bologna, 40136, Italy

RECRUITING

MeSH Terms

Conditions

Hemorrhage

Interventions

Embolization, Therapeutic

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hemostatic Techniques; Therapeutics; Therapeutic Occlusion

Central Study Contacts

Giancarlo Facchini

CONTACT

3336500944; giancarlo.facchini@ior.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: February 25, 2019
• Study Start: March 1, 2019
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 28, 2025

Record last verified: 2025-01

Locations

IT (1)