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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.

Recruiting
18-75 years
All
Phase N/A

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Overview

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

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 details
    Spine Metastasis
    Early Goal Directed Therapy
    Embolization
    Therapeutic
    Blood Loss

NCT03853434

Istituto Ortopedico Rizzoli

28 January 2024

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