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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Intraoperative blood loss
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Embolization
After angiography all metastases with poor/moderate vascularization will be embolized with acrylic glue in the treatment group.
干预措施: Embolization (Procedure)
No embolization
After angiography all metastasis with poor/moderate vascularization will not be embolized with acrylic glue in the control group
结局指标
主要结局
Intraoperative blood loss
时间窗: 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
次要结局
- 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)
- Concentration of Hemoglobin pre / post-operative(24 hours)
- duration of the hospitalization in ICU(during hospitalization)
- Correlation between primary tumor and vascularization(during angiographic procedure)
- incidence of complications related to transfusions;(during hospitalization)
- volume of transfused blood (ml)(intraoperatively)
- correlation between the type of primary tumor and blood losses(24 hours)
- evaluation of operative time, from incision to end of suture(during procedure)