An observational study in Brain Death, sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer. Completed at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Observational
The purpose of this study is to make a paramedical evaluation of a selection procedure of serious brain-injured patient in therapeutic abstention to a brain death state within 48 hours.
In 2016 in France, 5891 organs have been transplanted. All the transplant's sources are developed (brain death, Maastricht III, living organ donor).
However, the French Transplant's plan 2017-2021 require always more transplant, the aim is to reach 7800 transplants in 4 years.
To increase the number of transplants, one of the strategies is to actively identify the donors in brain death state and the donors with wider criteria. It's mainly serious brain-injured patients.
The procedure of early announcement of organ donation consists in beginning or pursues intensive care on serious brain-injured patient, for whom a decision of abstention of therapeutic active was decided. The only purpose of the medical care is to notice the brain death state that lead to donation.
In 2010, an expert group of the "Société de reanimation de langue Française" established guidelines to manage organ's donation in serious brain-injured patient after a stroke. The interest, to admit these serious brain-injured patients in intensive care unit, is to increase the number of donors in state of brain death and so the number of transplants.
However the guidelines remain little practised and little known in France. The number of bed in intensive care unit is limited and requires a selection of the potential organ donors. To hospitalised serious brain-injured patients in intensive care unit, there are no validated selection criteria that make difficult the implication of the transplant coordination in this anticipated announcement's approach.
In Toulon hospital, a standardize selection procedure was initiated and applied systematically by the transplant coordinator for each serious brain-injured patients. The selected patients will evolve in brain death state in 48 hours and could be organ donors.
The aim of this study is to validate a paramedical procedure to increase the number of organ donors.
74 studies on the registry are indexed under Brain Death; 10 are open to participants now.
This study's enrollment of 83 is close to the median of 80 across 33 observational studies indexed under Brain Death.
Browse Brain Death studies →Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer is the lead sponsor of 78 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Seriously brain-injured patient with therapeutic abstention
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Glasgow Coma Scale (GCS) :
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Study of the evolution to brain death state within 48 hours of seriously brain-injured patients selected by a standardized procedure and hospitalised in intensive care unit.
Rate of patients evolving to brain death state during the first 48 hours following the examination which validates patient's eligibility
Time frame: 48 hours after validation of eligibility
Evaluation of call rate to transplant coordination that don't result in a procedure of anticipated announcement
Ratio between the number of non-eligible patients and the total number of calls
Time frame: 48 hours after validation of eligibility
Evaluation of close family refusal rate for pursuit of care during 48h in intensive care unit
Ratio between the number of family refusal and the total number of patients for whom the anticipated announcement procedure was started.
Time frame: 48 hours after validation of eligibility
Number of refusal causes in the population
Number of refusal causes will be presented globally
Time frame: 48 hours after validation of eligibility
Evaluation of the delay between eligibility validation and the passage in brain death state.
The passage delay between eligibility validation and brain death state is defined by the time in hours between the examination which validates patient's eligibility and the diagnosis of brain death state.
Time frame: 48 hours after validation of eligibility
Evaluation of the rate of patients with organ removal in enrolled patients.
Ratio between the number of patient who performed organ donation and the total number of patients included.
Time frame: 48 hours after validation of eligibility
Number and type of organ harvested by patient.
Number of organs collected will be presented globally, by patient and by type of organ transplanted.
Time frame: 48 hours after validation of eligibility
Number of transplants performed.
The number of transplants performed will be presented globally, by patient and by type of organs.
Time frame: 10 days
Number of patient enrolled by type of service.
The number of patient enrolled in the intensive care unit, the Emergency or Neurovascular intensive care unit will be described globally
Time frame: 48 hours after validation of eligibility
Non harvested organs which have been suggested for transplant
The proportion of suggested non harvested organs will be determined as the number of suggested non harvested organs divided by the total number of non harvested organs. Reasons of suggested organs refusal will be presented.
Time frame: 10 days
Number of patients who performed Maastricht 3 organ donation among patients who didn't evolve to brain death state
The rate of patients with Maastricht 3 organ donation will be determined as the number of patients having performed Maastricht 3 organ donation divided by the number of patients who didn't evolve to brain death state after 48hours
Time frame: 10 days
Plan to share: No — no plan
No publications or documents are linked to this record.
Ran from Sep 2019 to primary completion in Sep 2024, 59 months.
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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer