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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

650 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-05

Study Completion Date

2021-10-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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