Status:
COMPLETED
The Anticipated Organ Donation Approach
Lead Sponsor:
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Collaborating Sponsors:
Centre Hospitalier Universitaire de Nice
Conditions:
Brain Death
Eligibility:
All Genders
18+ years
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 re...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
September 29 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 3 2024
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT03765814
Start Date
September 29 2019
End Date
October 3 2024
Last Update
November 20 2025
Active Locations (4)
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1
CH Annecy Genevois
Pringy, Haute Savoie, France, 74374
2
CHU de Nantes
Nantes, Loire-Atlantique, France, 44093
3
Centre Hospitalier Intercommunal Toulon La Seyne sur Mer
Toulon, Var, France, 83200
4
Centre Hospitalier Départemental de Vendée Les Oudairies
La Roche-sur-Yon, Vendée, France, 85000