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Sponsored by: |
Delafontaine Hospital |
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Information provided by: | Delafontaine Hospital |
ClinicalTrials.gov Identifier: | NCT00615225 |
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.
Condition | Intervention |
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Brain Death |
Procedure: Muscle biopsy |
Study Type: | Observational |
Official Title: | Observational Study on the Systemic Inflammatory Response During Brain Death. |
Study Start Date: | January 2000 |
Study Completion Date: | December 2007 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
---|---|
Brain dead patients
All patients meeting criteria for brain death
|
Procedure: Muscle biopsy
Muscle biopsies were taken through the operation site from the vastus lateralis thigh muscle at the beginning of surgery
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Healthy control
Any healthy volunteers accepting to give some blood
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Volunteers having hip surgery
Patients undergoing hip surgery for degenerative non-inflammatory hip disease
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Procedure: Muscle biopsy
Muscle biopsies were taken through the operation site from the vastus lateralis thigh muscle at the beginning of surgery
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Any brain dead patients diagnosed in three different ICUs
Inclusion Criteria:
Exclusion Criteria:
Belgium | |
Liege Hospital | |
Liege, Belgium | |
France | |
Delafontaine Hospital | |
Saint Denis, France, 93205 | |
Tenon Hospital | |
Paris, France, 75020 |
Principal Investigator: | Christophe Adrie, MD, PhD | Delafontaine Hospital |
Study Director: | Jean Marc Cavaillon, ScD | Pasteur Institute |
Responsible Party: | Delafotaine Hospital ( Christophe Adrie ) |
Study ID Numbers: | CCPPRB/114-02, Agence de Biomédecine 2005 |
Study First Received: | February 4, 2008 |
Last Updated: | February 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00615225 |
Health Authority: | France: Institutional Ethical Committee |
brain death inflammation endotoxin transplantation graft |
apoptosis Systemic inflammatory response Apoptosis activation Graft outcome |
Coma Unconsciousness Death Brain Death Consciousness Disorders |
Neurologic Manifestations Central Nervous System Diseases Brain Diseases Neurobehavioral Manifestations Inflammation |
Pathologic Processes Nervous System Diseases |