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| Tracking Information | |||||||||
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| First Received Date ICMJE | February 4, 2008 | ||||||||
| Last Updated Date | February 13, 2008 | ||||||||
| Start Date ICMJE | January 2000 | ||||||||
| Primary Completion Date | November 2007 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00615225 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Brain Death: Inflammatory Response, Apoptosis, and Endotoxin Tolerance | ||||||||
| Official Title ICMJE | Observational Study on the Systemic Inflammatory Response During Brain Death. | ||||||||
| Brief 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. 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. |
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| Detailed Description | |||||||||
| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | |||||||||
| Condition ICMJE | Brain Death | ||||||||
| Intervention ICMJE | Procedure: Muscle biopsy | ||||||||
| Study Arms / Comparison Groups |
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| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | |||||||||
| Completion Date | December 2007 | ||||||||
| Primary Completion Date | November 2007 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Belgium, France | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00615225 | ||||||||
| Responsible Party | Christophe Adrie, Delafotaine Hospital | ||||||||
| Study ID Numbers ICMJE | CCPPRB/114-02, Agence de Biomédecine 2005 | ||||||||
| Study Sponsor ICMJE | Delafontaine Hospital | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Delafontaine Hospital | ||||||||
| Verification Date | February 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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