NCT02758184终止不适用
Effectiveness of ROTEM-based Coagulation Surveillance on Reducing Blood Product Utilization During Complex Spine Surgery: A Prospective Randomized Study
Duke University2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2016年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Total Number of Units of Packed Red Blood Cells (PRBCs) Transfused
研究概览
简要总结
The Purpose of this study is to identify added value of Rotational thrombo-elastometry (ROTEM) intra-operative coagulation surveillance on reducing blood product use during major reconstructive spine surgery.
详细描述
The aim of the study is to evaluate the effectiveness of intra-operative ROTEM-based coagulation monitoring on reducing total blood product use during complex spine surgery.
The primary outcome will include estimated blood losses and blood product utilization during and after surgery (48 hours).
Secondary outcomes also include hospital length of stay, and cost analysis of the 2 methodologies.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 and < 80 years old.
- •Elective spine surgery cases, with a traditional open posterior approach and involving fusion of at least 5 levels.
- •Normal coagulation profile (PT/INR, aPTT) and normal platelets count on pre-operative evaluation.
- •Preoperative hemoglobin Level >10 g/dl.
- •OR time > 4 hours.
- •No contraindication for the use of anti-fibrinolytic therapy (Tranexamic acid).
排除标准
- •Age < 18 or age > 80 years old.
- •Anterior spine surgeries or posterior spine surgeries involving <5 levels.
- •Minimally invasive spine surgeries.
- •Patients with known coagulopathies or bleeding tendencies or patients with abnormal coagulation laboratory values at baseline.
- •Patients with Hemoglobin level of <10 g/dl on preoperative baseline laboratory values.
- •Trauma and Emergency spine surgeries.
- •Patients with spine malignancy diagnosis, either primary or metastatic.
- •OR time < 4 hours.
- •Patients who refuse to use allogenic blood products.
- •Patients with contraindications for the use of anti-fibrinolytic therapy.
结局指标
主要结局
Total Number of Units of Packed Red Blood Cells (PRBCs) Transfused
时间窗: up to 48 hours after surgery
Estimated Blood Loss (mL)
时间窗: during surgery (up to approximately 10 hours)
次要结局
- Amount of Recovered Blood Transfused During the Procedure (mL)(during surgery (up to approximately 10 hours))
- Cost Analysis, as Measured by Total Dollar Value of Blood Products Used(during surgery (up to approximately 10 hours))
- Drain Output (mL)(first 24 hours after surgery)
- Change in Hemoglobin (g/dL)(Baseline and approximately every 2 hours during surgery (up to approximately 10 hours))
- Length of Hospital Stay After Surgery(typically 5-7 days)
- Change in International Normalized Ratio (PT/INR)(Baseline and approximately every 2 hours during surgery (up to approximately 10 hours))
- Amount of Blood Products Transfused, Measured in Units(48 hours following surgery)
- Change in Platelet Count(Baseline and approximately every 2 hours during surgery (up to approximately 10 hours))
- Change in Prothrombin Time(Baseline and approximately every 2 hours during surgery (up to approximately 10 hours))
- Change in Activated Partial Thromboplastin Time (aPTT)(Baseline and approximately every 2 hours during surgery (up to approximately 10 hours))
- Change in Fibrinogen (g/L)(Baseline and approximately every 2 hours during surgery (up to approximately 10 hours))
研究者
研究点 (2)
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