Cyclosporine A Pretreatment and Kidney Graft Function
NCT02907554
Brain Death, Brain Diseases
Clermont-Ferrand, France
View Trial DetailsNCT Number: NCT03765814
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.
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Notify Me18 year and older
All sexes
Observational
CH Annecy Genevois, Pringy, Haute Savoie, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 48 hours after validation of eligibility
Ratio between the number of non-eligible patients and the total number of calls
Time frame: 48 hours after validation of eligibility
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 will be presented globally
Time frame: 48 hours after validation of eligibility
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
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 of organs collected will be presented globally, by patient and by type of organ transplanted.
Time frame: 10 days
The number of transplants performed will be presented globally, by patient and by type of organs.
Time frame: 48 hours after validation of eligibility
The number of patient enrolled in the intensive care unit, the Emergency or Neurovascular intensive care unit will be described globally
Time frame: 10 days
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
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
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Other
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
Acronym: PREMORENCE
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