Pre-recovery Bedside Liver Biopsy in Brain Death Organ Donors

Study Overview
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Brief Summary
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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.

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

Conditions
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Brain Death, Liver Disease

Intervention / Treatment
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* Procedure: Percutaneous Liver Biopsy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>In this group a liver biopsy will not be performed. All management would be as per standard of practice | |
| Active Comparator: Percutaneous liver biopsy<br>In this group a percutaneous biopsy of the liver will be performed prior to organ recovery | Procedure: Percutaneous Liver Biopsy<br>* 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.<br>* Other names: Bedside Liver Biopsy;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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donor management, Liver biopsy, organ donation