Preoperative Embolization in Surgical Treatment of Spinal Metastases. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Perioperative blood loss
研究概览
简要总结
The main purpose of this study is to assess the efficacy of preoperative embolization in decreasing operative blood loss, decreasing the need for intraoperative transfusion and facilitate surgical resection in metastatic spine surgery. Furthermore the study aims at describing the vascularity in a series of spinal metastasis, and to correlate this with perioperative blood loss.
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 (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for decompression and posterior thoracic and/or lumbar instrumented spinal fusion because of spinal metastasis/metastases.
- •Informed signed consent.
排除标准
- •Contrast fluid allergy.
- •Clotting disorders.
- •Renal failure.
- •Not suitable for arterial access.
- •Pregnancy.
研究组 & 干预措施
Preoperative embolization
32 patients with spinal metastasis/metastases will undergo arteriography and receive transcatheter arterial embolization of spinal metastasis/metastases 0-48 hours prior to surgery.
干预措施: Arteriography and preoperative embolization (Procedure)
Control group
32 patients with spinal metastasis/metastases will undergo arteriography of spinal metastasis/metastases without receiving transcatheter arterial embolization prior to surgery.
干预措施: Arteriography (Procedure)
结局指标
主要结局
Perioperative blood loss
时间窗: Measured intraoperatively and 24 hours postoperatively.
次要结局
- Perioperative blood transfusion volume(Intraoperatively and until 48 hours postoperatively.)
- Surgical procedure time.(At skin closure.)
- Vascularization grade of metastasis(At the angiographic procedure prior to embolization performed 0-48 hours before surgery.)
- Success of embolization(Directly after the embolization performed 0-48 hours before surgery.)
- Adverse events related to angiography or embolization(Within 2 postoperative days)
- Adverse events related to surgery(Within 2 postoperative days)
研究者
Caroline Clausen
MD
Rigshospitalet, Denmark