Brain DeathNCT00615225
Brain Death: Inflammatory Response, Apoptosis, and Endotoxin Tolerance
An observational study of Brain Death, run by Delafontaine Hospital at 3 sites in 2 countries.
Trial summary
We hypothesized that brain death is associated with an early systemic inflammatory response, possibly combined with activation of apoptotic cell death, two events that may contribute to induce rapid organ dysfunction. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Brain Death
- What is being tested?
- Muscle biopsy
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 3 sitesin 2 countries
- Study dates
- Jan 2000to Dec 2007
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Any brain dead patients diagnosed in three different ICUs
Who may be able to join
- All brain dead patients whatever the cause (cardiac arrest, stroke, head trauma)
Who cannot join
- Age < 18years
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
France2 sites
Tenon Hospital
Paris, 75020
Delafontaine Hospital
Saint-Denis, 93205
About this study
Official title: Observational Study on the Systemic Inflammatory Response During Brain Death.
We hypothesized that brain death is associated with an early systemic inflammatory response, possibly combined with activation of apoptotic cell death, two events that may contribute to induce rapid organ dysfunction. In this study of brain-dead donors and controls, we assayed plasma cytokines and soluble factors, investigated plasma endotoxin levels as a triggering factor for inflammation, measured ex vivo cytokine production by blood leukocytes to determine whether immunosuppression occurred after brain death, and examined skeletal muscle biopsies to look for evidence of inflammation and increased apoptosis in peripheral tissue.
- Conditions
- Brain Death
- Being tested
- Muscle biopsy
- Keywords
- brain death, inflammation, endotoxin, transplantation, graft, apoptosis, Systemic inflammatory response, Apoptosis activation, Graft outcome
- Medical subject headings
- Brain Death, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle biopsyProcedure or surgery
Muscle biopsies were taken through the operation site from the vastus lateralis thigh muscle at the beginning of surgery
| Study group | Role | What they receive |
|---|---|---|
| Brain dead patients | All patients meeting criteria for brain death Receives: Procedure: Muscle biopsy | |
| Healthy control | Any healthy volunteers accepting to give some blood | |
| Volunteers having hip surgery | Patients undergoing hip surgery for degenerative non-inflammatory hip disease Receives: Procedure: Muscle biopsy |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2008 (estimated)
- Study startJan 2000
- Primary completionNov 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DeathStudies of the same condition, open and under way.
- 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
Sponsor and investigators
- Lead sponsor
- Delafontaine Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Christophe Adrie, MD, PhD, Principal investigator, Delafontaine HospitalJean Marc Cavaillon, ScD, Study director, Pasteur Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00615225
- Sponsor's protocol ID
- CCPPRB/114-02
- Other IDs
- Agence de Biomédecine 2005
- Status last verified
- Feb 2008
- First submitted
- 4 Feb 2008
- Last updated
- 14 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Systemic Inflammatory Response During Brain Death.
- ClinicalTrials.gov ID
- NCT00615225
- Acronym / sponsor ID
- CCPPRB/114-02
- Conditions
- Brain Death
- Keywords
- brain death, inflammation, endotoxin, transplantation, graft, apoptosis, Systemic inflammatory response, Apoptosis activation
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Delafontaine HospitalUniversity, hospital or other
- Study start
- Jan 2000
- Primary completion
- Nov 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 14 Feb 2008 (estimated)
- 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.
We hypothesized that brain death is associated with an early systemic inflammatory response, possibly combined with activation of apoptotic cell death, two events that may contribute to induce rapid organ dysfunction. In this study of brain-dead donors and controls, we assayed plasma cytokines and soluble factors, investigated plasma endotoxin levels as a triggering factor for inflammation, measured ex vivo cytokine production by blood leukocytes to determine whether immunosuppression occurred after brain death, and examined skeletal muscle biopsies to look for evidence of inflammation and increased apoptosis in peripheral tissue.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brain dead patients | – | Procedure: Muscle biopsyAll patients meeting criteria for brain death |
| Healthy control | – | –Any healthy volunteers accepting to give some blood |
| Volunteers having hip surgery | – | Procedure: Muscle biopsyPatients undergoing hip surgery for degenerative non-inflammatory hip disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Any brain dead patients diagnosed in three different ICUs
Key inclusion criteria (1 listed)
- All brain dead patients whatever the cause (cardiac arrest, stroke, head trauma)
Key exclusion criteria (1 listed)
- Age < 18years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle biopsyMuscle biopsies were taken through the operation site from the vastus lateralis thigh muscle at the beginning of surgery | Procedure or surgery | Brain dead patients, Volunteers having hip surgery |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2008.
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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.
Christophe Adrie, MD, PhD principal investigator
Delafontaine Hospital
Jean Marc Cavaillon, ScD study director
Pasteur Institute
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Death, run by Delafontaine Hospital at 3 sites in 2 countries.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 14 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Belgium. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 14 Feb 2008.