NCT01331499终止4 期
A Post-Market, Prospective, Multicenter, Randomized Trial Comparing the Use of Standard of Care Blood Sparing Techniques With and Without the Aquamantys System to Facilitate Hemostasis in Subjects Undergoing Multi-level Spinal Fusions
Salient Surgical Technologies6 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2011年4月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 6
- 主要终点
- Actual Peri-operative Blood Loss
研究概览
简要总结
The purpose of this study is to compare standard of care hemostasis techniques with and without the use of Aquamantys in reducing peri-operative blood loss.
详细描述
The primary objective of the study is to assess the effectiveness of Aquamantys in reducing peri-operative blood loss compared with standard electrocautery
Secondary objectives include :
- Rate and volume of transfusions
- Evaluating the reduction in hemoglobin and hematocrit values post- operatively
- LOS costs, and operative time
- Gathering operator feedback on qualitative criteria, including ease of use and surgical visualization between the two treatment groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be candidate for three level (or greater) fusion surgery from T1 to S1 utilizing a direct posterior approach
- •Male or female 18 to 70 years of age (inclusive)
- •Must sign the IRB approved Informed Consent Form
排除标准
- •Undergoing spinal fusion for < 3 lumbar levels, or using an approach other than direct posterior
- •Undergoing an interbody fusion
- •Planned use of hypotensive anaesthesia
- •Pregnant or lactating
- •Morbid obesity, defined as Body Mass Index (BMI) greater than 40
- •Previously diagnosed coagulopathy or bleeding diasthesis
- •Currently, or within the previous 7 days prior to surgery, taking any medications that would produce bleeding diathesis including, but not limited to NSAIDs, aspirin, clopidogrel (Plavix), ticlopidine, or valproic acid
- •History of significant cardiac disorders that would necessitate special fluid management protocols
- •Serious trauma other than that confined to the spine
- •History of acute myocardial infarction and/or acute angina within the past year prior to enrollment
- •PT/INR >1.3 in the 14 days prior to surgery
- •PTT > 40 in the 14 days prior to surgery
- •Platelet count <100K in the 14 days prior to surgery
- •Based on clinical history, physical exam and subject presentation, subject has or is suspected to have a history of alcohol and/or drug abuse that would preclude subject from providing adequate consent and/or complying with study requirements
- •Prisoner or transient
- •Enrolled in another drug or device investigational study (currently or within past 30 days)
- •Unable or unwilling to sign the Informed Consent Form or comply with protocol specified procedures
结局指标
主要结局
Actual Peri-operative Blood Loss
时间窗: Up to 72 hours post-operatively
Actual blood loss (ABL) will be calculated using a study specified formula using laboratory data from up to 72 hours post-surgery. ABL will be compared between treatment groups
次要结局
- Frequency and volume of transfusions(Up to 72 hours post-operatively)
- Reduction in hemoglobin and hematocrit values post-operatively(Upto 72 hours post-operatively)
- Length of stay costs and operativ time(Up to 21 days post-operatively)
研究者
研究点 (6)
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