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Complications encountered with biopsy in first 6 patients
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Liver Biopsy | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 24hrs |
| Feasibility | The proportion of donors in the biopsy group in whom PPB information becomes available prior to commencement of organ recovery | 24hrs |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility | Time between performance of biopsy and availability of results to the sharing network | 24hrs |
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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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Babuaro Koneru, MD | UMDNJ - New Jersey Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Jersey Organ and Sharing Network | New Providence | New Jersey | 07974 | United States | ||
| University Hospital |
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| ID | Term |
|---|---|
| D001926 | Brain Death |
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003128 | Coma |
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|
|
| Newark |
| New Jersey |
| 07101 |
| United States |
| D014474 |
| Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004066 | Digestive System Diseases |