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

Stroke Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03612141
• Other study ID #: 2018-A02087-48
• Status: Recruiting
• Start date: February 5, 2019
• Est. completion date: October 2021

Study information

• Verified date: April 2019
• Source: Central Hospital, Nancy, France
• Contact: Lisa HUMBERTJEAN-SELTON
• Phone: 0383852256
• Email: l.humbertjean[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: October 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Death
• Stroke

Locations

Country	Name	City	State
France	CH d'Auxerre	Auxerre
France	Hôpital Nord Franche	Belfort
France	CHU Besançon	Besançon
France	CH de Chalons-en-Champagne	Châlons-en-Champagne
France	CH de Charleville-Mézières	Charleville-Mézières
France	CH de Colmar	Colmar
France	Ch de Compiègne	Compiègne
France	CHU de Dijon	Dijon
France	CH Epinal	Épinal
France	CH de Haguenau	Haguenau
France	CH de Laon	Laon
France	Lons Le Saunier	Lons-le-Saunier
France	CH de Macon	Mâcon
France	CHR Metz-Thionville	Metz
France	CH de Mulhouse	Mulhouse
France	CHRU de Nancy	Nancy
France	CH Nevers	Nevers
France	CHU de Reims	Reims
France	CH de Saint-Quentin	Saint-Quentin
France	CH Sarreguemines	Sarreguemines
France	CH de saverne	Saverne
France	CHRU de Strasbourg	Strasbourg
France	CH Troyes	Troyes
France	CH Verdun	Verdun
France	CH de Vesoul	Vesoul

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain death	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	5 days