Use of Observational Periods or Ancillary Tests in the Determination of Brain Death in Germany

Abstract

Background: In the absence of primary infratentorial brain lesions, the German guideline on brain death (BD) permits diagnosis based on two clinical assessments separated by a defined observational period or by one clinical assessment and an ancillary test.

Methods: Retrospective analysis of patients fulfilling the clinical criteria of BD registered with the organ procurement organization of northeastern Germany during a 10-year period.

Results: 2,745 patients were included. Compared to clinical observations, ancillary tests led to the confirmation of BD more frequently (98.7 vs. 78.7%) and after a considerably shorter diagnostic duration (median 1.4 vs. 16.5 h). Organ donation was more frequent with inclusion of ancillary tests (69.3 vs. 34.7% of diagnosed patients). The rate of fatal circulatory failure increased with longer observation. Nonconfirmatory results of the first ancillary test were more frequent with primary infratentorial lesions (14.3%) and hypoxic brain damage (7.9%) compared to primary supratentorial lesions (2.9%).

Conclusion: When used as an alternative to clinical reassessment, ancillary studies increase the rate of BD determination and organ donation. An increased rate of initially negative ancillary studies with infratentorial brain lesions or hypoxic brain damage supports the use of different diagnostic pathways for these patients, as defined by the current German guideline.