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

Last updated: April 9, 2019
Sponsor: Central Hospital, Nancy, France
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Cerebral Ischemia

Treatment

N/A

Clinical Study ID

NCT03612141
2018-A02087-48
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient aged 18 years and over.

  • Patient with a sever stroke less than 48 hours diagnosed by brain imaging magneticresonance 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 donationafter brain death

Exclusion

Exclusion Criteria:

  • Pregnant woman

  • Patient with recent traumatic brain injuries (subdural hematoma, extradural hematomaand contusions)

  • Obvious contraindication of organ donation excluding the patient from organ protectionmeasures 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

Total Participants: 650
Study Start date:
February 05, 2019
Estimated Completion Date:
October 31, 2021

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

Connect with a study center

  • CH d'Auxerre

    Auxerre,
    France

    Site Not Available

  • Hôpital Nord Franche

    Belfort,
    France

    Site Not Available

  • CHU Besançon

    Besançon,
    France

    Site Not Available

  • CH de Charleville-Mézières

    Charleville-Mézières,
    France

    Site Not Available

  • CH de Chalons-en-Champagne

    Châlons-en-Champagne,
    France

    Site Not Available

  • CH de Colmar

    Colmar,
    France

    Site Not Available

  • Ch de Compiègne

    Compiègne,
    France

    Site Not Available

  • CHU de Dijon

    Dijon,
    France

    Site Not Available

  • CH de Haguenau

    Haguenau,
    France

    Site Not Available

  • CH de Laon

    Laon,
    France

    Site Not Available

  • Lons Le Saunier

    Lons-le-Saunier,
    France

    Site Not Available

  • CHR Metz-Thionville

    Metz,
    France

    Active - Recruiting

  • CH de Mulhouse

    Mulhouse,
    France

    Site Not Available

  • CH de Macon

    Mâcon,
    France

    Site Not Available

  • CHRU de Nancy

    Nancy,
    France

    Active - Recruiting

  • CH Nevers

    Nevers,
    France

    Site Not Available

  • CHU de Reims

    Reims,
    France

    Site Not Available

  • CH de Saint-Quentin

    Saint-Quentin,
    France

    Site Not Available

  • CH Sarreguemines

    Sarreguemines,
    France

    Site Not Available

  • CH de saverne

    Saverne,
    France

    Site Not Available

  • CHRU de Strasbourg

    Strasbourg,
    France

    Site Not Available

  • CH Troyes

    Troyes,
    France

    Site Not Available

  • CH Verdun

    Verdun,
    France

    Site Not Available

  • CH de Vesoul

    Vesoul,
    France

    Site Not Available

  • CH Epinal

    Épinal,
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.