Pre-recovery Bedside Liver Biopsy in Brain Death Organ Donors (PPB)

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.

Study Overview

• Status: Terminated
• Conditions: Liver Disease; Brain Death
• Intervention / Treatment: Procedure: Percutaneous Liver Biopsy

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Providence, New Jersey, United States, 07974
      • New Jersey Organ and Sharing Network
    • Newark, New Jersey, United States, 07101
      • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; In this group a liver biopsy will not be performed. All management would be as per standard of practice
Active Comparator: Percutaneous liver biopsy; In this group a percutaneous biopsy of the liver will be performed prior to organ recovery	Procedure: Percutaneous Liver Biopsy; Using a 16 gauge Jamshidi biopsy needle, without image guidance, 3 passes will be completed to obtain core liver biopsies. Biopsies will be placed on wet saline and processed via frozen sample in OCT compound in 5 micron slices and stained with hematoxylin and eosin for microscopic evaluation. Slides will then be digitalized and shared on Donor.net.; Other Names: Bedside Liver Biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	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	6 hours
Reliability	Agreement of the findings of the bedside biopsy with reference to an intraoperative biopsy in histological characteristics of steatosis, inflammation, and fibrosis	24hrs
Feasibility	The proportion of donors in the biopsy group in whom PPB information becomes available prior to commencement of organ recovery	24hrs

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility	Time between performance of biopsy and availability of results to the sharing network	24hrs

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Babuaro Koneru, MD, UMDNJ - New Jersey Medical School

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: March 11, 2013
• First Submitted That Met QC Criteria: March 11, 2013
• First Posted (Estimate): March 13, 2013

Study Record Updates

• Last Update Posted (Estimate): May 13, 2015
• Last Update Submitted That Met QC Criteria: May 11, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: organ donation; Liver biopsy; donor management
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Unconsciousness; Consciousness Disorders; Coma; Liver Diseases; Death; Brain Death; Hematinics; Liver Extracts
• Other Study ID Numbers: 2012002002