NCT03612141

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
• Phase: —
• Study type: Observational
• Enrollment: 650 (estimated)
• Sponsor: Central Hospital, Nancy, France · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Stroke

Timeline

• Start date: 2019-02-05
• Primary completion: 2021-10-01
• Completion: 2021-10-01
• First posted: 2018-08-02
• Last updated: 2019-04-11

Locations

25 sites across 1 country: France