RecruitingNot ApplicableNCT03853434

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

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


Sponsor

Istituto Ortopedico Rizzoli

Enrollment

100 participants

Start Date

Mar 1, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

  • 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 Criteria9

  • 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.

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Interventions

PROCEDUREEmbolization

Angiographic embolization


Locations(1)

Giancarlo Facchini

Bologna, Italy

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NCT03853434


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