Pre-recovery Bedside Liver Biopsy in Brain Death Organ Donors



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:Any
Updated:5/5/2014
Start Date:February 2013
Contact:Babuaro Koneru, MD
Email:koneruba@umdnj.edu
Phone:9739729599

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Pre-recovery Percutaneous Biopsy of Livers in Neurological Death Organ Donors - A Pilot Study

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.


Inclusion Criteria:

- 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

1. Greater than 2 drinks of alcohol daily currently or in their history

2. Current IV drug use

3. Ultrasound, Computerized Tomography or other imaging modalities suggesting
cirrhosis

Exclusion Criteria:

- 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
We found this trial at
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Newark, New Jersey 07103
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New Providence, New Jersey 07974
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