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

Sponsor

Rutgers, The State University of New Jersey (Other)

Overall Status

Terminated

CT.gov ID

NCT01810640

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Death Liver Disease	Procedure: Percutaneous Liver Biopsy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Feb 1, 2013

Actual Primary Completion Date :

Jan 1, 2015

Actual Study Completion Date :

Feb 1, 2015

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Feasibility [24hrs]
Time between performance of biopsy and availability of results to the sharing network

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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

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