Thromboelastography-guided Fluid Management in Spinal Surgery: A Prospective Analysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Volume of transfused packed red blood cells
研究概览
简要总结
The Researchers are trying to evaluate whether using a blood test called thromboelastogram (TEG) to manage patients undergoing multi-level spinal fusion surgery will reduce complications after surgery compared with the standard practices.
详细描述
Multi-level instrumented spinal fusions represent an important treatment modality for degenerative scoliosis and sagittal malalignment. These surgeries remain a significant physiologic burden with high blood loss and long operative times. Thromboelastography provides a quantitative measure for blood product transfusion surrounding procedures. We aim to utilize thromboelastography to guide transfusions for multi-level spinal instrumentation. This two-arm, randomized, non-blinded prospective analysis will clarify reduced transfusion requirements for TEG-arm compared to non-TEG arm. We will also evaluate postoperative outcomes at the 1 year time-point.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patients undergoing elective multi-level spinal fusion for sagittal malalignment, multi-level spondylolisthesis, multi-level lumbar spinal stenosis, and adult degenerative scoliosis with ages between 18-89
排除标准
- •patients with tumors, infection, or trauma
结局指标
主要结局
Volume of transfused packed red blood cells
时间窗: post operative approximately 1 day
Amount of transfused packed red blood cells measured in units of cc(mL)
Estimated Blood Loss
时间窗: post operative approximately 1 day
Amount of blood loss measured in units of cc(mL)
Adverse Events
时间窗: One year
Number of adverse events reported
次要结局
未报告次要终点
研究者
Jamal McClendon, Jr.
Principal Investigator
Mayo Clinic