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

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ClinicalTrials.gov Identifier: NCT01810640
Recruitment Status : Terminated (Complications encountered with biopsy in first 6 patients)
First Posted : March 13, 2013
Last Update Posted : May 13, 2015
Sponsor:
Information provided by (Responsible Party):
Baburao Koneru, MD, Rutgers, The State University of New Jersey

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : February 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: 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 Name: Bedside Liver Biopsy




Primary Outcome Measures :
  1. Safety [ Time Frame: 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

  2. Reliability [ Time Frame: 24hrs ]
    Agreement of the findings of the bedside biopsy with reference to an intraoperative biopsy in histological characteristics of steatosis, inflammation, and fibrosis

  3. Feasibility [ Time Frame: 24hrs ]
    The proportion of donors in the biopsy group in whom PPB information becomes available prior to commencement of organ recovery


Secondary Outcome Measures :
  1. Feasibility [ Time Frame: 24hrs ]
    Time between performance of biopsy and availability of results to the sharing network



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01810640


Locations
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United States, New Jersey
New Jersey Organ and Sharing Network
New Providence, New Jersey, United States, 07974
University Hospital
Newark, New Jersey, United States, 07101
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
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Principal Investigator: Babuaro Koneru, MD UMDNJ - New Jersey Medical School

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Responsible Party: Baburao Koneru, MD, Professor of Surgery, Division Chief Liver Transplantation, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01810640     History of Changes
Other Study ID Numbers: 2012002002
First Posted: March 13, 2013    Key Record Dates
Last Update Posted: May 13, 2015
Last Verified: May 2015
Keywords provided by Baburao Koneru, MD, Rutgers, The State University of New Jersey:
Liver biopsy
organ donation
donor management
Additional relevant MeSH terms:
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Liver Diseases
Brain Death
Death
Digestive System Diseases
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Coma
Unconsciousness
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Liver Extracts
Hematinics