Back to resultsPre-recovery Bedside Liver Biopsy in Brain Death Organ Donors (PPB)
Primary Purpose
Brain Death, Liver Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Percutaneous Liver Biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Brain Death focused on measuring Liver biopsy, organ donation, donor management
Eligibility 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
- 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
Sites / Locations
- New Jersey Organ and Sharing Network
- University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control
Percutaneous liver biopsy
Arm Description
In this group a liver biopsy will not be performed. All management would be as per standard of practice
In this group a percutaneous biopsy of the liver will be performed prior to organ recovery
Outcomes
Primary Outcome Measures
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
Reliability
Agreement of the findings of the bedside biopsy with reference to an intraoperative biopsy in histological characteristics of steatosis, inflammation, and fibrosis
Feasibility
The proportion of donors in the biopsy group in whom PPB information becomes available prior to commencement of organ recovery
Secondary Outcome Measures
Feasibility
Time between performance of biopsy and availability of results to the sharing network
Full Information
NCT ID
NCT01810640
First Posted
March 11, 2013
Last Updated
May 11, 2015
Sponsor
Rutgers, The State University of New Jersey
1. Study Identification
Unique Protocol Identification Number
NCT01810640
Brief Title
Pre-recovery Bedside Liver Biopsy in Brain Death Organ Donors
Acronym
PPB
Official Title
Pre-recovery Percutaneous Biopsy of Livers in Neurological Death Organ Donors - A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Why Stopped
Complications encountered with biopsy in first 6 patients
Study Start Date
February 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Death, Liver Disease
Keywords
Liver biopsy, organ donation, donor management
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
In this group a liver biopsy will not be performed. All management would be as per standard of practice
Arm Title
Percutaneous liver biopsy
Arm Type
Active Comparator
Arm Description
In this group a percutaneous biopsy of the liver will be performed prior to organ recovery
Intervention Type
Procedure
Intervention Name(s)
Percutaneous Liver Biopsy
Other Intervention Name(s)
Bedside Liver Biopsy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety
Description
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
Time Frame
6 hours
Title
Reliability
Description
Agreement of the findings of the bedside biopsy with reference to an intraoperative biopsy in histological characteristics of steatosis, inflammation, and fibrosis
Time Frame
24hrs
Title
Feasibility
Description
The proportion of donors in the biopsy group in whom PPB information becomes available prior to commencement of organ recovery
Time Frame
24hrs
Secondary Outcome Measure Information:
Title
Feasibility
Description
Time between performance of biopsy and availability of results to the sharing network
Time Frame
24hrs
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Babuaro Koneru, MD
Organizational Affiliation
UMDNJ - New Jersey Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Jersey Organ and Sharing Network
City
New Providence
State/Province
New Jersey
ZIP/Postal Code
07974
Country
United States
Facility Name
University Hospital
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07101
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pre-recovery Bedside Liver Biopsy in Brain Death Organ Donors
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