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

Rutgers The State University of New Jersey

Status: Terminated

Conditions: Brain Death; Liver Disease

Treatments: Procedure: Percutaneous Liver Biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT01810640

2012002002

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: All

Volunteers: No 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

  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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Control

No Intervention group

Description:

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

Percutaneous liver biopsy

Active Comparator group

Description:

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

Treatment:

Procedure: Percutaneous Liver Biopsy