Interest of Real Time Measurement of Autonomous Nervous System for the Detection of Brain Death (MEANS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00918970|
Recruitment Status : Terminated (Angioscanners in excess of the SNA group because of use of thiopental)
First Posted : June 11, 2009
Last Update Posted : June 15, 2009
Context: A major lack of organ donors is a serious public health problem. It determines a prolonged delay before a transplant can be performed and thus a significant number of deaths of patients waiting for transplantation. The aim of this project is to reduce the delay of the diagnosis of brain death, and also to improve its diagnosis in the Intensive Care Unit.
The diagnosis of brain death is strictly defined by the law and relies either on two consecutive flat electroencephalograms recorded at an interval of four hours, or on the lack of cerebral circulation during a brain angiography performed after suspecting brain death on the clinical exam. However, in usual practice, it is difficult to have all the needed clinical arguments, and their interpretation can be difficult in the pathological context. This may participate in the delay and the lack of patients potentially donors.
Pre-study: In a pilot study, fifty subjects with severe cerebral lesions, had a continuous ECG recording. The investigators could find that a decrease in autonomic nervous system activity, as measured through the ECG, was correlated to the transition to brain death assessed by cerebral angiography. The loss of cardiac variability was always observed between two cerebral angiographies, one before and the second after brain death. This study allowed the investigators to calculate the threshold values of sympathetic and parasympathetic activities to confirm brain death.
|Condition or disease|
|Cerebral Hematoma, Traumatic Intracerebral Hemorrhage, Traumatic Traumatic Brain Hemorrhage Traumatic Brain Injury|
Aim: The aim of this second study is to validate prospectively the interest of the analysis in real-time of autonomic nervous system activity to detect brain death.
Benefits expected: Increase the number of organ donors and the number of organs removal available for transplantation.
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||Interest of Real Time Measurement of Autonomous Nervous System for the Detection of Brain Death: the MEANS Study|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
This group will have a real-time analysis of autonomic nervous system activity during its intensive care hospitalisation
This group will have a conventional clinical analysis during its intensive care hospitalisation
- the delay between the falling down of autonomic nervous system activity and the confirmation of the brain death using cerebral angiography [ Time Frame: At confirmation of the brain death ]
- the number of patients and the number of organs removed [ Time Frame: At the end of the study ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00918970
|CHU de Dijon|
|Dijon, France, 21000|
|Roanne, France, 42700|
|CHU de Saint-Etienne|
|Saint-etienne, France, 42055|
|Principal Investigator:||David CHARIER, MD||CHU de Saint-Etienne|