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

NCT03612141 | Unknown

• 1 other identifier: 2018-A02087-48
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 25

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.

Conditions

Stroke

Keywords

Severe stroke; Brain Death; organ donation

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who will be included in this study will be * Patients with a severe stroke admitted in a stroke unit or a intensive care unit * With a engaged vital prognosis ( life threatened pateint) * With non opposition to organ donation

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (25)

CH d'Auxerre

Auxerre, France

NOT YET RECRUITING

Hôpital Nord Franche

Belfort, France

NOT YET RECRUITING

CHU Besançon

Besançon, France

NOT YET RECRUITING

CH de Charleville-Mézières

Charleville-Mézières, France

NOT YET RECRUITING

CH de Chalons-en-Champagne

Châlons-en-Champagne, France

NOT YET RECRUITING

CH de Colmar

Colmar, France

NOT YET RECRUITING

Ch de Compiègne

Compiègne, France

NOT YET RECRUITING

CHU de Dijon

Dijon, France

NOT YET RECRUITING

CH Epinal

Épinal, France

RECRUITING

CH de Haguenau

Haguenau, France

NOT YET RECRUITING

CH de Laon

Laon, France

NOT YET RECRUITING

Lons Le Saunier

Lons-le-Saunier, France

NOT YET RECRUITING

CH de Macon

Mâcon, France

NOT YET RECRUITING

CHR Metz-Thionville

Metz, France

RECRUITING

CH de Mulhouse

Mulhouse, France

NOT YET RECRUITING

CHRU de Nancy

Nancy, France

RECRUITING

CH Nevers

Nevers, France

NOT YET RECRUITING

CHU de Reims

Reims, France

NOT YET RECRUITING

CH de Saint-Quentin

Saint-Quentin, France

NOT YET RECRUITING

CH Sarreguemines

Sarreguemines, France

NOT YET RECRUITING

CH de saverne

Saverne, France

NOT YET RECRUITING

CHRU de Strasbourg

Strasbourg, France

NOT YET RECRUITING

CH Troyes

Troyes, France

NOT YET RECRUITING

CH Verdun

Verdun, France

NOT YET RECRUITING

CH de Vesoul

Vesoul, France

NOT YET RECRUITING

Related 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.

  PMID: 26402792 BACKGROUND

MeSH Terms

Conditions

Stroke; Brain Death

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Coma; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lisa HUMBERTJEAN-SELTON

CONTACT

0383852256; l.humbertjean@chru-nancy.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 2, 2018
• Study Start: February 5, 2019
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: April 11, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (25)