Clinical trial NCT01810640: Pre-recovery Bedside Liver Biopsy in Brain Death Organ Donors
Official title: Pre-recovery Percutaneous Biopsy of Livers in Neurological Death Organ Donors - A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Brain Death
Liver Disease
Keywords: Liver biopsy
organ donation
donor management
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2013-03-13
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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, 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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety
timeFrame: 6 hours
measure: Reliability
timeFrame: 24hrs
measure: Feasibility
timeFrame: 24hrs
Secondary outcomes:
measure: Feasibility
timeFrame: 24hrs
Other outcomes:
Locations:
city: New Providence
country: United States
facility: New Jersey Organ and Sharing Network
state: New Jersey
city: Newark
country: United States
facility: University Hospital
state: New Jersey
Study officials:
affiliation: UMDNJ - New Jersey Medical School
name: Babuaro Koneru, MD
role: PRINCIPAL_INVESTIGATOR
References: