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

Blood Loss Clinical Trial

— Embart  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03853434
• Other study ID #: Embart
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Blood Loss
• Blood Loss, Surgical
• Early Goal Directed Therapy
• Embolization, Therapeutic
• Hemorrhage
• Neoplasm Metastasis
• Spine Metastasis

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