Clinical trial NCT03853434: Efficacy of Angiographic Embolization vs Non-embolization of Moderate/Poor Vascularized Vertebral Metastases on Intraoperative Bleeding During Surgery Decompression and Vertebral Stabilization.
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spine Metastasis
Early Goal Directed Therapy
Embolization, Therapeutic
Blood Loss
Keywords: embolization
blood loss
Early Goal Directed Therapy
spine metastasis
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2019-02-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Intraoperative blood loss
timeFrame: during procedure
Secondary outcomes:
measure: Concentration of Hemoglobin pre / post-operative
timeFrame: 24 hours
measure: volume of transfused blood (ml)
timeFrame: intraoperatively
measure: Correlation between primary tumor and vascularization
timeFrame: during angiographic procedure
measure: correlation between the type of primary tumor and blood losses
timeFrame: 24 hours
measure: technical evaluation of the final result of embolization (total - 100%, subtotal 90-80% and partial 70-50%) in relation to blood losses
timeFrame: during angiographic procedure
measure: evaluation of operative time, from incision to end of suture
timeFrame: during procedure
measure: incidence of complications related to transfusions;
timeFrame: during hospitalization
measure: duration of the hospitalization in ICU
timeFrame: during hospitalization
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Giancarlo Facchini
Study officials:
References: