Blood Loss, Early Goal Directed Therapy, Embolization, Therapeutic, Spine Metastasis
Conditions
Keywords
embolization, blood loss, Early Goal Directed Therapy, spine metastasis
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.
Interventions
PROCEDUREEmbolization
Angiographic embolization
Sponsors
Istituto Ortopedico Rizzoli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative blood loss | during procedure | volume (ml) of intraoperative blood loss volume aspirated from operative field (ml) + differential weight gauze at the end of surgery - dry gauze weight with 1g blood conversion = 0.948ml |
Secondary
| Measure | Time frame |
|---|---|
| Concentration of Hemoglobin pre / post-operative | 24 hours |
| volume of transfused blood (ml) | intraoperatively |
| Correlation between primary tumor and vascularization | during angiographic procedure |
| correlation between the type of primary tumor and blood losses | 24 hours |
| technical evaluation of the final result of embolization (total - 100%, subtotal 90-80% and partial 70-50%) in relation to blood losses | during angiographic procedure |
| evaluation of operative time, from incision to end of suture | during procedure |
| incidence of complications related to transfusions; | during hospitalization |
| duration of the hospitalization in ICU | during hospitalization |
Countries
Italy
Outcome results
None listed