NCT01810640

Pre-recovery Bedside Liver Biopsy in Brain Death Organ Donors

Pre-recovery Percutaneous Biopsy of Livers in Neurological Death Organ Donors - A Pilot Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Brain Death
• Liver Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-02-01
• Primary completion: 2015-01-01
• Completion: 2015-02-01
• First posted: 2013-03-13
• Last updated: 2015-05-13

Locations

2 sites across 1 country: United States