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

April 9, 2019 updated by: Central Hospital, Nancy, France

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

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.

Study Overview

Status

Unknown

Conditions

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

Study Type

Observational

Enrollment (Anticipated)

650

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Auxerre, France
        • Not yet recruiting
        • CH d'Auxerre
      • Belfort, France
        • Not yet recruiting
        • Hôpital Nord Franche
      • Besançon, France
        • Not yet recruiting
        • CHU Besançon
      • Charleville-Mézières, France
        • Not yet recruiting
        • CH de Charleville-Mézières
      • Châlons-en-Champagne, France
        • Not yet recruiting
        • CH de Châlons-en-Champagne
      • Colmar, France
        • Not yet recruiting
        • CH de Colmar
      • Compiègne, France
        • Not yet recruiting
        • CH de Compiègne
      • Dijon, France
        • Not yet recruiting
        • CHU de Dijon
      • Haguenau, France
        • Not yet recruiting
        • Ch de Haguenau
      • Laon, France
        • Not yet recruiting
        • CH de Laon
      • Lons-le-Saunier, France
        • Not yet recruiting
        • Lons Le Saunier
      • Metz, France
        • Recruiting
        • CHR Metz-Thionville
      • Mulhouse, France
        • Not yet recruiting
        • CH de Mulhouse
      • Mâcon, France
        • Not yet recruiting
        • CH de Macon
      • Nancy, France
        • Recruiting
        • CHRU de Nancy
        • Contact:
          • Lisa Humbertjean-Selton
      • Nevers, France
        • Not yet recruiting
        • CH Nevers
      • Reims, France
        • Not yet recruiting
        • CHU de Reims
      • Saint-Quentin, France
        • Not yet recruiting
        • Ch de Saint-Quentin
      • Sarreguemines, France
        • Not yet recruiting
        • CH Sarreguemines
      • Saverne, France
        • Not yet recruiting
        • CH de saverne
      • Strasbourg, France
        • Not yet recruiting
        • CHRU de Strasbourg
      • Troyes, France
        • Not yet recruiting
        • CH Troyes
      • Verdun, France
        • Not yet recruiting
        • CH Verdun
      • Vesoul, France
        • Not yet recruiting
        • CH de Vesoul
      • Épinal, France
        • Recruiting
        • CH Epinal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain death
Time Frame: 5 days

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2019

Primary Completion (Anticipated)

October 1, 2021

Study Completion (Anticipated)

October 1, 2021

Study Registration Dates

First Submitted

July 26, 2018

First Submitted That Met QC Criteria

August 1, 2018

First Posted (Actual)

August 2, 2018

Study Record Updates

Last Update Posted (Actual)

April 11, 2019

Last Update Submitted That Met QC Criteria

April 9, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-A02087-48

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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