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

Last updated: January 24, 2025
Sponsor: Istituto Ortopedico Rizzoli
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hemorrhage

Neoplasm Metastasis

Treatment

Embolization

Clinical Study ID

NCT03853434
Embart
  • Ages 18-75
  • All Genders

Study 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 Criteria

Inclusion

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

Exclusion Criteria:

  • congenital and iatrogenic hemocoagulative disorders (PT INR> 1.5, aPTT ratio> 1.25with documented coagulation factor deficiency, PLT < 80,000 / microL or knowncoagulation 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 Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Embolization
Phase:
Study Start date:
March 01, 2019
Estimated Completion Date:
December 31, 2028

Connect with a study center

  • Giancarlo Facchini

    Bologna, 40136
    Italy

    Active - Recruiting

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