StrokeDIAPASON1NCT03612141
Extern Validation of a Predictive Score of Brain Death in Severe Stroke (DIAPASON1)
An observational study of Stroke, run by Central Hospital, Nancy, France at 25 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- How many people
- 650 participants
- Where
- 25 sitesFrance
- Study dates
- 5 Feb 2019to Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
France25 sites, 25 recruiting
- Not yet recruiting
CH d'Auxerre
Auxerre
- Not yet recruiting
Hôpital Nord Franche
Belfort
- Not yet recruiting
CHU Besançon
Besançon
- Not yet recruiting
CH de Chalons-en-Champagne
Châlons-en-Champagne
- Not yet recruiting
CH de Charleville-Mézières
Charleville-Mézières
- Not yet recruiting
CH de Colmar
Colmar
- Not yet recruiting
Ch de Compiègne
Compiègne
- Not yet recruiting
CHU de Dijon
Dijon
- Recruiting
CH Epinal
Épinal
- Not yet recruiting
CH de Haguenau
Haguenau
- Not yet recruiting
CH de Laon
Laon
- Not yet recruiting
Lons Le Saunier
Lons-le-Saunier
- Not yet recruiting
CH de Macon
Mâcon
- Recruiting
CHR Metz-Thionville
Metz
- Not yet recruiting
CH de Mulhouse
Mulhouse
- Recruiting
CHRU de Nancy
Nancy
Lisa Humbertjean-Selton
- Not yet recruiting
CH Nevers
Nevers
- Not yet recruiting
CHU de Reims
Reims
- Not yet recruiting
CH de Saint-Quentin
Saint-Quentin
- Not yet recruiting
CH Sarreguemines
Sarreguemines
- Not yet recruiting
CH de saverne
Saverne
- Not yet recruiting
CHRU de Strasbourg
Strasbourg
- Not yet recruiting
CH Troyes
Troyes
- Not yet recruiting
CH Verdun
Verdun
- Not yet recruiting
CH de Vesoul
Vesoul
About this study
Official title: 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.
Read the 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
- Keywords
- Severe stroke, Brain Death, organ donation
- Medical subject headings
- Stroke, Brain Death
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start5 Feb 2019
- Primary completionOct 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612141
- Sponsor's protocol ID
- 2018-A02087-48
- Acronym
- DIAPASON1
- Status last verified
- Apr 2019
- First submitted
- 26 Jul 2018
- Last updated
- 11 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26402792
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extern Validation of a Predictive Score of Brain Death in Patients With Severe Stroke and Unfavourable Prognosis Identified by Organ Procurement and Transplant Coordinations
- ClinicalTrials.gov ID
- NCT03612141
- Acronym / sponsor ID
- DIAPASON1 / 2018-A02087-48
- Conditions
- Stroke
- Keywords
- Severe stroke, Brain Death, organ donation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 5 Feb 2019 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 2 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
- Background: PubMed 26402792Humbertjean 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Central Hospital, Nancy, France at 25 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa HUMBERTJEAN-SELTON (0383852256 ext. 0033, l.humbertjean@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain death (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03612141, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2019.