Pre-recovery Bedside Liver Biopsy in Brain Death Organ Donors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-02-28

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.

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Detailed Description

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Conditions

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Brain Death Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Percutaneous liver biopsy

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

Group Type ACTIVE_COMPARATOR

Percutaneous Liver Biopsy

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Bedside Liver Biopsy

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

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No