Pre-recovery Percutaneous Biopsy of Livers in Neurological Death Organ Donors - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 4
- 主要终点
- Safety
研究概览
简要总结
This study's objective is to obtain preliminary data to test the hypotheses that percutaneous liver biopsy in brain death donors is safe and provides reliable histological information. Furthermore, that information when disseminated fully and widely many hours before organ recovery would not only decrease economic costs of wasteful recovery of livers that are not ultimately transplanted but also increase transplantation and decrease cold ischemia times of recovered livers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neurological death donors in whom brain death determination is imminent
- •First person or next of kin consent for research becomes available
- •High risk donor, as defined by the following criteria i) Known liver disease ii) Hepatitis BsAg, BcAb, B DNA, Hepatitis C Ab or Hepatitis C RNA positivity iii) Age >= 50 iv) Any of the following risk factors for fatty liver disease a) BMI >= 30 b) History of Type 2 Diabetes Mellitus c) Ultrasound, Computerized Tomography or other imaging modalities suggesting steatosis v) Any of the following risk factors for chronic liver disease
- •Greater than 2 drinks of alcohol daily currently or in their history
- •Current IV drug use
- •Ultrasound, Computerized Tomography or other imaging modalities suggesting cirrhosis
排除标准
- •Donation after cardiac death donors
- •Live organ donors
- •No first person consent and next of kin decline research consent
- •Donors in whom it has been established the liver will not be shared
- •Donors in whom percutaneous liver biopsy has been performed within the past month for any indication and the biopsy results are available and considered reliable.
- •Donor with a contraindication to liver biopsy, including INR > 2, PTT > 75, Platelets < 70,000, history of coagulopathy, current or recent use (within 7 days) of antiplatelet agent such as aspirin or Plavix, and hemodynamic instability defined as a MAP less than 65mmHg.
- •Inability to position donor appropriately for performance of PPB
- •Unavailability of pathology staff to analyze specimen in a timely manner
结局指标
主要结局
Safety
时间窗: 6 hours
Safety of bedside liver biopsy will be measured as the presence or absence of a composite outcome of: change in hemoglobin (gm/dL) from baseline of greater than 2, occurence of pneumothorax on right side observed on chest X-ray immediately after biopsy, and/or donor instability leading to expedited organ recover, and/or loss of donor organs attributed to the biopsy
Reliability
时间窗: 24hrs
Agreement of the findings of the bedside biopsy with reference to an intraoperative biopsy in histological characteristics of steatosis, inflammation, and fibrosis
Feasibility
时间窗: 24hrs
The proportion of donors in the biopsy group in whom PPB information becomes available prior to commencement of organ recovery
次要结局
- Feasibility(24hrs)
研究者
Baburao Koneru, MD
Professor of Surgery, Division Chief Liver Transplantation
Rutgers, The State University of New Jersey