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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03853434
Other study ID # Embart
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2019
Est. completion date December 1, 2024

Study information

Verified date July 2023
Source Istituto Ortopedico Rizzoli
Contact Giancarlo Facchini
Phone 3336500944
Email giancarlo.facchini@ior.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 1, 2024
Est. primary completion date February 22, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
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 Design


Intervention

Procedure:
Embolization
Angiographic embolization

Locations

Country Name City State
Italy Giancarlo Facchini Bologna

Sponsors (1)

Lead Sponsor Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Intraoperative blood loss 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 during procedure
Secondary Concentration of Hemoglobin pre / post-operative 24 hours
Secondary volume of transfused blood (ml) intraoperatively
Secondary Correlation between primary tumor and vascularization during angiographic procedure
Secondary correlation between the type of primary tumor and blood losses 24 hours
Secondary 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
Secondary evaluation of operative time, from incision to end of suture during procedure
Secondary incidence of complications related to transfusions; during hospitalization
Secondary duration of the hospitalization in ICU during hospitalization
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