Clinical Trial: Pre-recovery Bedside Liver Biopsy in Brain Death Organ Donors
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Pre-recovery Percutaneous Biopsy of Livers in Neurological Death Organ Donors - A Pilot Study
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.
Detailed Summary:
Sponsor: Rutgers, The State University of New Jersey
Current 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
Original Primary Outcome: Same as current
Current Secondary Outcome: Feasibility [ Time Frame: 24hrs ]
Original Secondary Outcome: Same as current
Information By: Rutgers, The State University of New Jersey
Dates:
Date Received: March 11, 2013
Date Started: February 2013
Date Completion:
Last Updated: May 11, 2015
Last Verified: May 2015
