Pre-recovery Bedside Liver Biopsy in Brain Death Organ Donors

Liver Disease Clinical Trial

— PPB  

Official title:

Pre-recovery Percutaneous Biopsy of Livers in Neurological Death Organ Donors - A Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01810640
• Other study ID #: 2012002002
• Status: Terminated
• Phase: N/A
• First received: March 11, 2013
• Last updated: May 11, 2015
• Start date: February 2013
• Est. completion date: February 2015

Study information

• Verified date: May 2015
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: February 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Brain Death
• Death
• Liver Disease
• Liver Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	New Jersey Organ and Sharing Network	New Providence	New Jersey
United States	University Hospital	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Reliability	Agreement of the findings of the bedside biopsy with reference to an intraoperative biopsy in histological characteristics of steatosis, inflammation, and fibrosis	24hrs	No
Primary	Feasibility	The proportion of donors in the biopsy group in whom PPB information becomes available prior to commencement of organ recovery	24hrs	No
Secondary	Feasibility	Time between performance of biopsy and availability of results to the sharing network	24hrs	No