Back to resultsEfficacy of Angiographic Embolization vs Non-embolization of Moderate/Poor Vascularized Vertebral Metastases on Intraoperative Bleeding During Surgery Decompression and Vertebral Stabilization. (Embart)
Primary Purpose
Spine Metastasis, Early Goal Directed Therapy, Embolization, Therapeutic
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Embolization
Sponsored by
About this trial
This is an interventional treatment trial for Spine Metastasis focused on measuring embolization, blood loss, Early Goal Directed Therapy, spine metastasis
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.
Sites / Locations
- Giancarlo FacchiniRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Embolization
No embolization
Arm Description
After angiography all metastases with poor/moderate vascularization will be embolized with acrylic glue in the treatment group.
After angiography all metastasis with poor/moderate vascularization will not be embolized with acrylic glue in the control group
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Concentration of Hemoglobin pre / post-operative
volume of transfused blood (ml)
Correlation between primary tumor and vascularization
correlation between the type of primary tumor and blood losses
technical evaluation of the final result of embolization (total - 100%, subtotal 90-80% and partial 70-50%) in relation to blood losses
evaluation of operative time, from incision to end of suture
incidence of complications related to transfusions;
duration of the hospitalization in ICU
Full Information
NCT ID
NCT03853434
First Posted
January 15, 2019
Last Updated
July 19, 2023
Sponsor
Istituto Ortopedico Rizzoli
1. Study Identification
Unique Protocol Identification Number
NCT03853434
Brief Title
Efficacy of Angiographic Embolization vs Non-embolization of Moderate/Poor Vascularized Vertebral Metastases on Intraoperative Bleeding During Surgery Decompression and Vertebral Stabilization.
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
February 22, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto Ortopedico Rizzoli
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spine Metastasis, Early Goal Directed Therapy, Embolization, Therapeutic, Blood Loss
Keywords
embolization, blood loss, Early Goal Directed Therapy, spine metastasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Embolization
Arm Type
Experimental
Arm Description
After angiography all metastases with poor/moderate vascularization will be embolized with acrylic glue in the treatment group.
Arm Title
No embolization
Arm Type
No Intervention
Arm Description
After angiography all metastasis with poor/moderate vascularization will not be embolized with acrylic glue in the control group
Intervention Type
Procedure
Intervention Name(s)
Embolization
Intervention Description
Angiographic embolization
Primary Outcome Measure Information:
Title
Intraoperative blood loss
Description
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
Time Frame
during procedure
Secondary Outcome Measure Information:
Title
Concentration of Hemoglobin pre / post-operative
Time Frame
24 hours
Title
volume of transfused blood (ml)
Time Frame
intraoperatively
Title
Correlation between primary tumor and vascularization
Time Frame
during angiographic procedure
Title
correlation between the type of primary tumor and blood losses
Time Frame
24 hours
Title
technical evaluation of the final result of embolization (total - 100%, subtotal 90-80% and partial 70-50%) in relation to blood losses
Time Frame
during angiographic procedure
Title
evaluation of operative time, from incision to end of suture
Time Frame
during procedure
Title
incidence of complications related to transfusions;
Time Frame
during hospitalization
Title
duration of the hospitalization in ICU
Time Frame
during hospitalization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giancarlo Facchini
Phone
3336500944
Email
giancarlo.facchini@ior.it
Facility Information:
Facility Name
Giancarlo Facchini
City
Bologna
ZIP/Postal Code
40136
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giancarlo Facchini
Phone
3336500944
Email
giancarlo.facchini@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy of Angiographic Embolization vs Non-embolization of Moderate/Poor Vascularized Vertebral Metastases on Intraoperative Bleeding During Surgery Decompression and Vertebral Stabilization.
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