Extern Validation of a Predictive Score of Brain Death in Severe Stroke (DIAPASON1)

• Conditions: Stroke

• Registration Number: NCT03612141
• Lead Sponsor: Central Hospital, Nancy, France

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

Study Timeline

• Study First Submitted: 2018-07-26
• Study First Submitted QC: 2018-08-01
• Study First Posted: 2018-08-02
• Study Start: 2019-02-05
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-09
• Last Update Posted: 2019-04-11
• Primary Completion: 2021-10
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 650

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brain death	5 days	Brain death defined confirmed by the mandatory criteria of the current French legislation for organ procurement including in the absence of confounding factors such as sedation, deep hypothermia, severe metabolic disorders): * clinical assessment (absence of consciousness (Glasgow score =3), absence of spontaneous respiration absence of brain stem reflexes); * paraclinical assessment: two flat and areactive electroencephalography recordings or cerebral angiography/cerebral CT scanshowing no cerebral circulation

Trial Locations

Locations (25)

Ch de Compiègne; 🇫🇷 Compiègne, France

CHRU de Strasbourg; 🇫🇷 Strasbourg, France

CH de Saint-Quentin; 🇫🇷 Saint-Quentin, France

CH de Macon; 🇫🇷 Mâcon, France

CHU de Reims; 🇫🇷 Reims, France

CHU Besançon; 🇫🇷 Besançon, France

Hôpital Nord Franche; 🇫🇷 Belfort, France

CH de Mulhouse; 🇫🇷 Mulhouse, France

CHU de Dijon; 🇫🇷 Dijon, France

CH d'Auxerre; 🇫🇷 Auxerre, France

CH de Charleville-Mézières; 🇫🇷 Charleville-Mézières, France

CH Sarreguemines; 🇫🇷 Sarreguemines, France

CH de Chalons-en-Champagne; 🇫🇷 Châlons-en-Champagne, France

CH de Colmar; 🇫🇷 Colmar, France

CH de Haguenau; 🇫🇷 Haguenau, France

CH de Laon; 🇫🇷 Laon, France

Lons Le Saunier; 🇫🇷 Lons-le-Saunier, France

CHR Metz-Thionville; 🇫🇷 Metz, France

CHRU de Nancy; 🇫🇷 Nancy, France

CH Nevers; 🇫🇷 Nevers, France

CH de saverne; 🇫🇷 Saverne, France

CH Troyes; 🇫🇷 Troyes, France

CH Verdun; 🇫🇷 Verdun, France

CH de Vesoul; 🇫🇷 Vesoul, France

CH Epinal; 🇫🇷 Épinal, France