NCT00615225

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 14, 2008

Completed
Last Updated

February 14, 2008

Status Verified

February 1, 2008

Enrollment Period

7.8 years

First QC Date

February 4, 2008

Last Update Submit

February 13, 2008

Conditions

Brain Death

Keywords

brain deathinflammationendotoxintransplantationgraftapoptosisSystemic inflammatory responseApoptosis activationGraft outcome

Study Arms (3)

Brain dead patients

All patients meeting criteria for brain death

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

Procedure: Muscle biopsy

Interventions

Muscle biopsyPROCEDURE

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

Brain dead patientsVolunteers having hip surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any brain dead patients diagnosed in three different ICUs

You may qualify if:

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

You may not qualify if:

  • Age \< 18years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Liege Hospital

Liège, Belgium

Location

Tenon Hospital

Paris, 75020, France

Location

Delafontaine Hospital

Saint-Denis, 93205, France

Location

MeSH Terms

Conditions

Brain DeathInflammation

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesComaUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christophe Adrie, MD, PhD

    Delafontaine Hospital

    PRINCIPAL INVESTIGATOR

  • Jean Marc Cavaillon, ScD

    Pasteur Institute

    STUDY DIRECTOR

Study Design

Study Type
observational
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 4, 2008

First Posted

February 14, 2008

Study Start

January 1, 2000

Primary Completion

November 1, 2007

Study Completion

December 1, 2007

Last Updated

February 14, 2008

Record last verified: 2008-02

Locations

FR(2)BE(1)