Brain DeathPPBNCT01810640
Pre-recovery Bedside Liver Biopsy in Brain Death Organ Donors
A study testing Percutaneous Liver Biopsy in people with Brain Death and Liver Disease, run by Rutgers, The State University of New Jersey at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Death, Liver Disease
- What is being tested?
- Percutaneous Liver Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2013to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
New Jersey Organ and Sharing Network
New Providence, New Jersey, 07974
University Hospital
Newark, New Jersey, 07101
About this study
Official title: Pre-recovery Percutaneous Biopsy of Livers in Neurological Death Organ Donors - A Pilot Study
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.
- Conditions
- Brain Death, Liver Disease
- Being tested
- Percutaneous Liver Biopsy
- Keywords
- Liver biopsy, organ donation, donor management
- Medical subject headings
- Brain Death, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Liver BiopsyProcedure or surgery
Also called Bedside 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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | In this group a liver biopsy will not be performed. All management would be as per standard of practice |
| Percutaneous liver biopsy | Active comparator | In this group a percutaneous biopsy of the liver will be performed prior to organ recovery Receives: Procedure: Percutaneous Liver Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 24hrs
Feasibility
The proportion of donors in the biopsy group in whom PPB information becomes available prior to commencement of organ recovery
Measured: 24hrs
Secondary outcomes (1)
Feasibility
Time between performance of biopsy and availability of results to the sharing network
Measured: 24hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionJan 2015
- Study completionFeb 2015
Why it stopped: Complications encountered with biopsy in first 6 patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DeathStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baburao Koneru, MD, Rutgers, The State University of New Jersey
- Investigators
- Babuaro Koneru, MD, Principal investigator, UMDNJ - New Jersey Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810640
- Sponsor's protocol ID
- 2012002002
- Acronym
- PPB
- Status last verified
- May 2015
- First submitted
- 11 Mar 2013
- Last updated
- 13 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-recovery Percutaneous Biopsy of Livers in Neurological Death Organ Donors - A Pilot Study
- ClinicalTrials.gov ID
- NCT01810640
- Acronym / sponsor ID
- PPB / 2012002002
- Conditions
- Brain Death, Liver Disease
- Keywords
- Liver biopsy, organ donation, donor management
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Complications encountered with biopsy in first 6 patients
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Jan 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 13 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –In this group a liver biopsy will not be performed. All management would be as per standard of practice |
| Percutaneous liver biopsy | Active comparator | Procedure: Percutaneous Liver BiopsyIn this group a percutaneous biopsy of the liver will be performed prior to organ recovery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous Liver BiopsyAlso: Bedside Liver BiopsyUsing 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. | Procedure or surgery | Percutaneous liver biopsy |
Primary outcome
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
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
Feasibility
Time frame: 24hrs
The proportion of donors in the biopsy group in whom PPB information becomes available prior to commencement of organ recovery
1 secondary outcome
Feasibility
Time frame: 24hrs
Results and safety
The study was stopped early (reason given: Complications encountered with biopsy in first 6 patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Babuaro Koneru, MD principal investigator
UMDNJ - New Jersey Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Liver Biopsy in people with Brain Death and Liver Disease, run by Rutgers, The State University of New Jersey at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Complications encountered with biopsy in first 6 patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: 6 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2015.