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Brain Death: Inflammatory Response, Apoptosis, and Endotoxin Tolerance

Primary Purpose

Brain Death

Status

Completed

Phase

Locations

International

Study Type

Observational

Intervention

Muscle biopsy

About this trial

This is an observational trial for Brain Death focused on measuring brain death, inflammation, endotoxin, transplantation, graft, apoptosis, Systemic inflammatory response, Apoptosis activation, Graft outcome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

All brain dead patients whatever the cause (cardiac arrest, stroke, head trauma)

Exclusion Criteria:

Age < 18years

Sites / Locations

Liege Hospital
Tenon Hospital
Delafontaine Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Arm Label

Brain dead patients

Healthy control

Volunteers having hip surgery

Arm Description

All patients meeting criteria for brain death

Any healthy volunteers accepting to give some blood

Patients undergoing hip surgery for degenerative non-inflammatory hip disease

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00615225

First Posted

February 4, 2008

Last Updated

February 13, 2008

Sponsor

Delafontaine Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00615225

Brief Title

Brain Death: Inflammatory Response, Apoptosis, and Endotoxin Tolerance

Official Title

Observational Study on the Systemic Inflammatory Response During Brain Death.

Study Type

Observational

2. Study Status

Record Verification Date

February 2008

Overall Recruitment Status

Completed

Study Start Date

January 2000 (undefined)

Primary Completion Date

November 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Delafontaine Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Death

Keywords

brain death, inflammation, endotoxin, transplantation, graft, apoptosis, Systemic inflammatory response, Apoptosis activation, Graft outcome

7. Study Design

8. Arms, Groups, and Interventions

Arm Title

Brain dead patients

Arm Description

All patients meeting criteria for brain death

Arm Title

Healthy control

Arm Description

Any healthy volunteers accepting to give some blood

Arm Title

Volunteers having hip surgery

Arm Description

Patients undergoing hip surgery for degenerative non-inflammatory hip disease

Intervention Type

Procedure

Intervention Name(s)

Muscle biopsy

Intervention Description

Muscle biopsies were taken through the operation site from the vastus lateralis thigh muscle at the beginning of surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All brain dead patients whatever the cause (cardiac arrest, stroke, head trauma) Exclusion Criteria: Age < 18years

Study Population Description

Any brain dead patients diagnosed in three different ICUs

Sampling Method

Non-Probability Sample

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christophe Adrie, MD, PhD

Organizational Affiliation

Delafontaine Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jean Marc Cavaillon, ScD

Organizational Affiliation

Pasteur Institute

Official's Role

Study Director

Facility Information:

Facility Name

Liege Hospital

City

Liege

Country

Belgium

Facility Name

Tenon Hospital

City

Paris

ZIP/Postal Code

75020

Country

France

Facility Name

Delafontaine Hospital

City

Saint Denis

ZIP/Postal Code

93205

Country

France

12. IPD Sharing Statement

Learn more about this trial

Brain Death: Inflammatory Response, Apoptosis, and Endotoxin Tolerance

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