Interest of Real Time Measurement of Autonomous Nervous System for the Detection of Brain Death

Traumatic Brain Injury Clinical Trial

— MEANS  

Official title:

Interest of Real Time Measurement of Autonomous Nervous System for the Detection of Brain Death: the MEANS Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00918970
• Other study ID #: 0708045
• Secondary ID: CNIL 908.476
• Status: Terminated
• Phase: N/A
• First received: June 8, 2009
• Last updated: June 12, 2009
• Start date: August 2008
• Est. completion date: June 2009

Study information

• Verified date: June 2009
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection Authority
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• severe cerebral lesions

• admitted in intensive care units

Exclusion Criteria:

• neoplastic pathology

• prior myocardiac infarction

• hearth failure

• atrial fibrillation

• insulin-treated diabetes mellitus

• cardiac pacemaker

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Death
• Brain Hemorrhage, Traumatic
• Cerebral Hematoma, Traumatic
• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage, Traumatic
• Traumatic Brain Hemorrhage
• Traumatic Brain Injury

Locations

Country	Name	City	State
France	CHU de Dijon	Dijon
France	CH Roanne	Roanne
France	CHU de Saint-Etienne	Saint-etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the delay between the falling down of autonomic nervous system activity and the confirmation of the brain death using cerebral angiography		At confirmation of the brain death	No
Secondary	the number of patients and the number of organs removed		At the end of the study	No