Registry AutoLog Lipid Removal and Blood Component Characterization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 199
- 试验地点
- 6
- 主要终点
- level of reduction of nonemulsified fat
研究概览
简要总结
The purpose of this study is to show the success of the AutoLog System in removing lipids to less than 10mg/dl in vivo. The Autolog registry has two objectives:
- to determine the lipid removal capabilities of the Medtronic AutoLog System.
- to obtain in vivo data on blood component removal and washing capabilities of the Medtronic AutoLog System.
详细描述
Since the in house data strongly suggest that the Medtronic AutoLog is uniquely high performing in lipid removal in-vitro, the Registry AutoLog Lipid Removal and Blood Component Characterization is initiated to determine if the AutoLog system is successful in removing lipids in vivo as it is in-vitro. Therefore, it is expected that the lipid amounts after washing will be less than 10 mg/dl.
The study is designed as a multi-center, non-randomized, non-interventional, post market release study (a registry). The study has a single arm, without controls, as it is descriptive in nature.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an indication for surgery procedures in which the hospital treatment protocol requires the routine use of an autotransfusion system are eligible for participation.
排除标准
- •The use of citrate-based anticoagulant in patients with impaired liver function
- •Gross contamination and/or septic procedures
- •Surgery within the malignant area that may allow dissemination of tumor/malignant cells, if aspirated, into the autotransfusion system
- •Caesarean sections in presence of amniotic fluid
- •Presence of high concentrations of prostatic fluid
- •Contamination of salvaged blood with drugs not intended for intravenous administration
- •Use of collagen-based haemostatic agents and gel foam used in combination with any autotransfusion system
- •Coagulopathy
- •Not willing to sign a Patient Informed Consent/Data Release Form
结局指标
主要结局
level of reduction of nonemulsified fat
时间窗: after process
The primary endpoint of this study is the level of reduction of nonemulsified fat after processing through the Medtronic AutoLog.
次要结局
未报告次要终点