Pre-recovery Bedside Liver Biopsy in Brain Death Organ Donors

Stopped early · Not applicable

Conditions studied: Brain Death, Liver Disease

In brief

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.

Key facts

Study ID

NCT01810640

Run by

Rutgers, The State University of New Jersey

People needed

6

Starts

2013-02-01

Expected to finish

2015-02-01

Last updated by the study team

2015-05-13

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• New Jersey Organ and Sharing Network — New Providence, New Jersey, United States
• University Hospital — Newark, New Jersey, United States

Full record on ClinicalTrials.gov

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