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

Extern Validation of a Predictive Score of Brain Death in Patients With Severe Stroke and Unfavourable Prognosis Identified by Organ Procurement and Transplant Coordinations

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03612141
Acronym
DIAPASON1
Enrollment
650
Registered
2018-08-02
Start date
2019-02-05
Completion date
2021-10-31
Last updated
2019-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

Keywords

Severe stroke, Brain Death, 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

Interventions

None listed

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Brain death5 daysBrain 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

Countries

France

Contacts

Primary ContactLisa HUMBERTJEAN-SELTON
l.humbertjean@chru-nancy.fr0383852256

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026