Pre-recovery Bedside Liver Biopsy in Brain Death Organ Donors

Not Applicable

Terminated

• Conditions: Brain Death; Liver Disease
• Interventions: Procedure: Percutaneous Liver Biopsy

• Registration Number: NCT01810640
• Lead Sponsor: Rutgers, The State University of New Jersey

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-03-11
• Study First Submitted QC: 2013-03-11
• Study First Posted: 2013-03-13
• Primary Completion: 2015-01
• Study Completion: 2015-02
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-11
• Last Update Posted: 2015-05-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Percutaneous liver biopsy	Percutaneous Liver Biopsy	In this group a percutaneous biopsy of the liver will be performed prior to organ recovery

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Feasibility	24hrs	Time between performance of biopsy and availability of results to the sharing network

Trial Locations

Locations (2)

University Hospital; 🇺🇸 Newark, New Jersey, United States

New Jersey Organ and Sharing Network; 🇺🇸 New Providence, New Jersey, United States