Clinical trial NCT03765814: The Anticipated Organ Donation Approach
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Death
Keywords: organ donation
serious brain-injured patient
anticipated approach
Lead sponsor: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Nice
First posted: 2018-12-05
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Seriously brain-injured patient with therapeutic abstention

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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)

Primary outcomes:
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.
timeFrame: 48 hours after validation of eligibility
Secondary outcomes:
measure: Evaluation of call rate to transplant coordination that don't result in a procedure of anticipated announcement
timeFrame: 48 hours after validation of eligibility
measure: Evaluation of close family refusal rate for pursuit of care during 48h in intensive care unit
timeFrame: 48 hours after validation of eligibility
measure: Number of refusal causes in the population
timeFrame: 48 hours after validation of eligibility
measure: Evaluation of the delay between eligibility validation and the passage in brain death state.
timeFrame: 48 hours after validation of eligibility
measure: Evaluation of the rate of patients with organ removal in enrolled patients.
timeFrame: 48 hours after validation of eligibility
measure: Number and type of organ harvested by patient.
timeFrame: 48 hours after validation of eligibility
measure: Number of transplants performed.
timeFrame: 10 days
measure: Number of patient enrolled by type of service.
timeFrame: 48 hours after validation of eligibility
measure: Non harvested organs which have been suggested for transplant
timeFrame: 10 days
measure: Number of patients who performed Maastricht 3 organ donation among patients who didn't evolve to brain death state
timeFrame: 10 days
Other outcomes:
Locations:
city: Pringy
country: France
facility: CH Annecy Genevois
state: Haute Savoie
city: Nantes
country: France
facility: CHU de Nantes
state: Loire-Atlantique
city: Toulon
country: France
facility: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
state: Var
city: La Roche-sur-Yon
country: France
facility: Centre Hospitalier Départemental de Vendée Les Oudairies
state: Vendée
Study officials:
affiliation: Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
name: Valérie Arsonneau
role: STUDY_DIRECTOR
References: