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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2028-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Spine Metastasis Early Goal Directed Therapy Embolization, Therapeutic Blood Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Embolization

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

Group Type EXPERIMENTAL

Embolization

Intervention Type PROCEDURE

Angiographic embolization

No embolization

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Embolization

Angiographic embolization

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No