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Difficulties in recruitment.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Embolization | Experimental | After angiography all metastases with poor/moderate vascularization will be embolized with acrylic glue in the treatment group. |
|
| No embolization | No Intervention | After angiography all metastasis with poor/moderate vascularization will not be embolized with acrylic glue in the control group |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Embolization | Procedure | Angiographic embolization |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of Hemoglobin pre / post-operative | 24 hours | |
| volume of transfused blood (ml) | intraoperatively | |
| Correlation between primary tumor and vascularization |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Giancarlo Facchini | Bologna | 40136 | Italy |
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| 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 |
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004621 | Embolization, Therapeutic |
| ID | Term |
|---|---|
| D006489 | Hemostatic Techniques |
| D013812 | Therapeutics |
| D060205 | Therapeutic Occlusion |
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