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

Istituto Ortopedico Rizzoli

Status

Enrolling

Conditions

Early Goal Directed Therapy

Embolization, Therapeutic

Spine Metastasis

Blood Loss

Treatments

Procedure: Embolization

Study type

Interventional

Funder types

Other

Identifiers

NCT03853434

Embart

Details and patient eligibility

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.