Pre-recovery Bedside Liver Biopsy in Brain Death Organ Donors

NCT01810640 | Terminated

• 1 other identifier: 2012002002
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Brain Death; Liver Disease

Keywords

Liver biopsy; organ donation; donor management

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Feasibility

  24hrs

Study Arms (2)

Control

NO INTERVENTION

In this group a liver biopsy will not be performed. All management would be as per standard of practice

Percutaneous liver biopsy

ACTIVE COMPARATOR

In this group a percutaneous biopsy of the liver will be performed prior to organ recovery

Procedure: Percutaneous Liver Biopsy

Interventions

Percutaneous Liver Biopsy PROCEDURE

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.

Also known as: Bedside Liver Biopsy

Percutaneous liver biopsy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (2)

New Jersey Organ and Sharing Network

New Providence, New Jersey, 07974, United States

Location

University Hospital

Newark, New Jersey, 07101, United States

Location

MeSH Terms

Conditions

Brain Death; Liver Diseases

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Coma; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Digestive System Diseases

Study Officials

• Babuaro Koneru, MD

  UMDNJ - New Jersey Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery, Division Chief Liver Transplantation

Study Record Dates

• First Submitted: March 11, 2013
• First Posted: March 13, 2013
• Study Start: February 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: February 1, 2015
• Last Updated: May 13, 2015

Record last verified: 2015-05

Locations

US (2)