Brain DeathPREMORENCENCT03765814
The Anticipated Organ Donation Approach
An observational study of Brain Death, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 4 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Death
- How many people
- 83 participants
- Where
- 4 sitesFrance
- Study dates
- 29 Sep 2019to 3 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Seriously brain-injured patient with therapeutic abstention
Who may be able to join
- Male or Female over 18 years-old
- Patient with serious brain damages
- Medical decision of withdrawing life sustaining treatment
- Signed and dated informed consent by trusted person, or family
- Patient covered by social security regimen
- Patient eligible for organ donation according to organ donation hospital co-ordination
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- Glasgow Coma Scale (GCS) :
- Seriously brain-injured patient without confounding factors, head trauma, brain anoxia or ischemic stroke : GCS<5 and loss of bilateral corneal reflex or GCS<5 and loss of three brain stem reflexes
- Seriously brain-injured patient with confounding factors and without head trauma, brain anoxia or ischemic stroke : at least one of the following scanographic sign of gravity : deletion of subarachnoid cisterns, more than 15 mm deviation of the median line, hematoma volume > 65 cm3 or hydrocephalus due to intra-ventricular bleeding with V3 or V4 flood, and, if documented, a GCS<7.
- Patient with head trauma, brain anoxia or ischemic stroke, reliable clinical examination required (no confounding factor) : GCS<5 and loss of bilateral corneal reflex or GCS<5 and loss of three brain stem reflexes
Who cannot join
- No trusted person or family present
- Seriously brain-injured patient because of head trauma, brain anoxia or ischemic stroke with confounding factors
- Absolute contraindication to organ donation known at the moment of inclusion (HIV, rabies, active cancer, active tuberculosis, Creutzfeldt-Jakob disease)
Trial locations and contacts
4 sites in 1 country.
France4 sites
Centre Hospitalier Départemental de Vendée Les Oudairies
La Roche-sur-Yon, Vendée, 85000
CHU de Nantes
Nantes, Loire-Atlantique, 44093
CH Annecy Genevois
Pringy, Haute Savoie, 74374
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Toulon, Var, 83200
About this study
Official title: Paramedical Evaluation of a Standardize Procedure of Selection of Serious Brain-injured Patients in Therapeutic Abstention to a Brain Death State in the First 48h
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.
Read the detailed description
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.
- Conditions
- Brain Death
- Keywords
- organ donation, serious brain-injured patient, anticipated approach
- Medical subject headings
- Brain Death
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 48 hours after validation of eligibility
Secondary outcomes (10)
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
Measured: 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.
Measured: 48 hours after validation of eligibility
Number of refusal causes in the population
Number of refusal causes will be presented globally
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start29 Sep 2019
- Primary completion23 Sep 2024
- Study completion3 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nice
- Responsible party
- Sponsor
- Investigators
- Valérie Arsonneau, Study director, Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765814
- Sponsor's protocol ID
- 2018-CHITS-02
- Other IDs
- 2018-A01455-50
- Acronym
- PREMORENCE
- Status last verified
- Jul 2026
- First submitted
- 22 Nov 2018
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paramedical Evaluation of a Standardize Procedure of Selection of Serious Brain-injured Patients in Therapeutic Abstention to a Brain Death State in the First 48h
- ClinicalTrials.gov ID
- NCT03765814
- Acronym / sponsor ID
- PREMORENCE / 2018-CHITS-02
- Conditions
- Brain Death
- Keywords
- organ donation, serious brain-injured patient, anticipated approach
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Nice
- Study start
- 29 Sep 2019 (actual)
- Primary completion
- 23 Sep 2024 (actual)
- Study completion
- 3 Oct 2024 (actual)
- First posted
- 5 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Seriously brain-injured patient with therapeutic abstention
Key inclusion criteria (10 listed)
- Male or Female over 18 years-old
- Patient with serious brain damages
- Medical decision of withdrawing life sustaining treatment
- Signed and dated informed consent by trusted person, or family
- Patient covered by social security regimen
Key exclusion criteria (3 listed)
- No trusted person or family present
- Seriously brain-injured patient because of head trauma, brain anoxia or ischemic stroke with confounding factors
- Absolute contraindication to organ donation known at the moment of inclusion (HIV, rabies, active cancer, active tuberculosis, Creutzfeldt-Jakob disease)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 48 hours after validation of eligibility
Rate of patients evolving to brain death state during the first 48 hours following the examination which validates patient's eligibility
10 secondary outcomes
Evaluation of call rate to transplant coordination that don't result in a procedure of anticipated announcement
Time frame: 48 hours after validation of eligibility
Evaluation of close family refusal rate for pursuit of care during 48h in intensive care unit
Time frame: 48 hours after validation of eligibility
Number of refusal causes in the population
Time frame: 48 hours after validation of eligibility
Evaluation of the delay between eligibility validation and the passage in brain death state.
Time frame: 48 hours after validation of eligibility
Evaluation of the rate of patients with organ removal in enrolled patients.
Time frame: 48 hours after validation of eligibility
Number and type of organ harvested by patient.
Time frame: 48 hours after validation of eligibility
Number of transplants performed.
Time frame: 10 days
Number of patient enrolled by type of service.
Time frame: 48 hours after validation of eligibility
Non harvested organs which have been suggested for transplant
Time frame: 10 days
Number of patients who performed Maastricht 3 organ donation among patients who didn't evolve to brain death state
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No. no plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valérie Arsonneau study director
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Death, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 48 hours after validation of eligibility). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.