A National Multicenter Trial on Family Presence During Brain Death Determination: The FABRA Study

Abstract

As brain death is a difficult concept for the lay public to understand, we hypothesized that allowing relatives of the patient to be present during brain death determination would improve their understanding of this condition and would eventually lead to an increased consent rate for organ donation. A prospective multicenter trial was conducted in five Dutch hospitals. Relatives were given the opportunity to be present during brain death testing. The family consent rate for organ donation was the primary endpoint examined, and the degree of the relatives' understanding of brain death was the secondary endpoint. Between April 2010 and July 2011, we included the relatives of 8 patients in this study. The relatives witnessed brain death testing during this time. This sample size was too small to draw valid statistical conclusions. However, we have documented some noteworthy experiences of the relatives. Although, the hypothesis behind this study had promise, we were unable to reach our predefined goal. The possible causes for this shortcoming included the rarity of patients with brain death, the common practice in the Netherlands of obtaining consent for organ donation before brain death testing and the uneasiness of the staff in the presence of the patients' relatives during brain death determination. Although, we cannot draw a conclusion from statistical evidence, we would recommend that relatives be given the opportunity to be present during brain death testing and, specifically, during the apnea test.