Status:
TERMINATED
Pre-recovery Bedside Liver Biopsy in Brain Death Organ Donors
Lead Sponsor:
Rutgers, The State University of New Jersey
Conditions:
Brain Death
Liver Disease
Eligibility:
All Genders
Phase:
NA
Brief Summary
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, th...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01810640
Start Date
February 1 2013
End Date
February 1 2015
Last Update
May 13 2015
Active Locations (2)
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1
New Jersey Organ and Sharing Network
New Providence, New Jersey, United States, 07974
2
University Hospital
Newark, New Jersey, United States, 07101