Clinical trial NCT03612141: Extern Validation of a Predictive Score of Brain Death in Severe Stroke (DIAPASON1)
Official title: Extern Validation of a Predictive Score of Brain Death in Patients With Severe Stroke and Unfavourable Prognosis Identified by Organ Procurement and Transplant Coordinations
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke
Keywords: Severe stroke
Brain Death
organ donation
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 650
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: Patients who will be included in this study will be

* Patients with a severe stroke admitted in a stroke unit or a intensive care unit
* With a engaged vital prognosis ( life threatened pateint)
* With non opposition to organ donation

Brief summary: There is currently a shortage of organ in France, for patients with chronic diseases who are on the waiting list for an organ. The first source of organ donor in France is patients with brain death. 58% of patients in brain death are patients with a severe stroke ( ischemic or hemorrhagic). In order to identify which patient with a severe stroke and with unfavorable prognosis who can evolve to brain death, we have conducted a retrospective study in Lorrain, in France, and we have built a predictive score of brain death in these patients. It is important to validate this predictive score in a prospective study on a greater scale than the first study.

Detailed description: Main objective :

External validation of a brain death evolution predictive score GRAHAL65 (initial Glasgow score ≤6, systolic blood pressure \>150 mmHg, past history of alcohol abuse, herniation, hydrocephalus, and stroke volume\>65 ml) for patients with severe stroke and withhold therapy built.

Secondary objectives :

Identification of other clinical and paraclinical predictive factors of brain death evolution:

* Age,sex,
* Temperature and glycemia
* Rostro-caudal abolition of brainstem reflexes
* Other cardiovascular risk factors (hypertension, diabetes, atrial fibrillation, dyslipidemia,)
* Antiplatelet therapy, anticoagulant treatment,
* Intravenous thrombolytic therapy or thrombectomy
* Type of stroke
* Infarct location
* Type of brain herniation

Eligibility criteria: Inclusion Criteria:

* Patient aged 18 years and over.
* Patient with a sever stroke less than 48 hours diagnosed by brain imaging magnetic resonance imaging or computed tomography (including cerebral infarction, intra-parenchymal hemorrhage and subarachnoid haemorrhage
* Patient with Glasgow Scale score \<8 Engaged vital prognosis
* Absence of therapeutic resources
* Decision of resuscitation measures to protect the organs in the purpose organ donation after brain death

Exclusion Criteria:

* Pregnant woman
* Patient with recent traumatic brain injuries (subdural hematoma, extradural hematoma and contusions)
* Obvious contraindication of organ donation excluding the patient from organ protection measures in intensive care unit (expression of patient opposition, HIV infection, active tuberculosis, spongiform encephalopathy,
* human growth hormones treatment origin, rabies, active cancer)
* Opposition of family member of the patient

Primary outcomes:
measure: Brain death
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Auxerre
country: France
facility: CH d'Auxerre
city: Belfort
country: France
facility: Hôpital Nord Franche
city: Besançon
country: France
facility: CHU Besançon
city: Charleville-Mézières
country: France
facility: CH de Charleville-Mézières
city: Châlons-en-Champagne
country: France
facility: CH de Chalons-en-Champagne
city: Colmar
country: France
facility: CH de Colmar
city: Compiègne
country: France
facility: Ch de Compiègne
city: Dijon
country: France
facility: CHU de Dijon
city: Haguenau
country: France
facility: CH de Haguenau
city: Laon
country: France
facility: CH de Laon
city: Lons-le-Saunier
country: France
facility: Lons Le Saunier
city: Metz
country: France
facility: CHR Metz-Thionville
city: Mulhouse
country: France
facility: CH de Mulhouse
city: Mâcon
country: France
facility: CH de Macon
city: Nancy
country: France
facility: CHRU de Nancy
city: Nevers
country: France
facility: CH Nevers
city: Reims
country: France
facility: CHU de Reims
city: Saint-Quentin
country: France
facility: CH de Saint-Quentin
city: Sarreguemines
country: France
facility: CH Sarreguemines
city: Saverne
country: France
facility: CH de saverne
city: Strasbourg
country: France
facility: CHRU de Strasbourg
city: Troyes
country: France
facility: CH Troyes
city: Verdun
country: France
facility: CH Verdun
city: Vesoul
country: France
facility: CH de Vesoul
city: Épinal
country: France
facility: CH Epinal
Study officials:
References:
citation: Humbertjean L, Mione G, Fay R, Durin L, Planel S, Lacour JC, Enea AM, Richard S. Predictive factors of brain death in severe stroke patients identified by organ procurement and transplant coordination in Lorrain, France. Transpl Int. 2016 Mar;29(3):299-306. doi: 10.1111/tri.12695.