NCT00498498

Brief Summary

The goal of this study is to answer the following questions:

  • What is the time course of the expected changes in endothelin levels during the first two weeks after injury and how does this relate to outcome?
  • What is the relation between endothelin levels (big ET-1 and ET-1) in plasma and cerebrospinal fluid and type of injury, from CT scans and GCS?
  • What is the relation between endothelin levels (big ET-1 and ET-1) in plasma and cerebrospinal fluid and outcome measurements like GOSE, ICP and CT scans?
  • What is the relation between neurohormones related to the neutral endopeptidase (NEP) (ANP, BNP and cGMP) in plasma and cerebrospinal fluid and type of injury, from CT scans and GCS?
  • What is the relation between endothelin levels (big ET-1 and ET-1) in plasma and cerebrospinal fluid and markers for apoptosis?

Trial Health

90
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2007

Typical duration for all trials

Geographic Reach
4 countries

11 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

July 1, 2007

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 10, 2007

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

November 16, 2011

Status Verified

November 1, 2011

Enrollment Period

1.9 years

First QC Date

July 9, 2007

Last Update Submit

November 15, 2011

Conditions

Cerebrovascular TraumaNeurohormonesCellular ApoptosisEndothelin System

Keywords

severe head injuryEndothelinCSFPlasmaCellular Apoptosis

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Fifty patients will be enrolled in this trial. Subjects will be eligible who have severe traumatic brain injury (the majority of patients) or moderate TBI together with lesions on CT scans sufficient to warrant placement of ventriculostomy catheter.

You may qualify if:

  • Informed consent obtained before collection of blood and CSF is commenced.
  • TBI diagnosed by history, clinical examination with GCS of 8 or less, and head CT scan and placement of ventriculostomy catheter
  • Patients with GCS 9 -12 who undergo placement of a ventriculostomy because of the severity of the CT lesion may be included
  • Patients will be enrolled in the study within the first 8 hours after injury
  • At least one reactive pupil after injury
  • Age 18-70

You may not qualify if:

  • Life expectancy of less than 8 hours as determined by the investigator
  • Associated spinal cord injury
  • Patients with penetrating head injury will be excluded
  • Inability to establish ventriculostomy drainage
  • Severe cardiac or hemodynamic instability consistent with point #1 above
  • Receipt of any known investigational drug within 30 days prior to this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

University of California, Davis

Sacramento, California, 95817, United States

Location

Harbor UCLA Medical Center

Torrance, California, 90509, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

University of Iowa Hospital

Iowa City, Iowa, 52242, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

The Mayfield Clinic

Cincinnati, Ohio, 45219, United States

Location

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

University Hospital Heidelberg

Heidelberg, D-69120, Germany

Location

University of Padova Medical School

Padua, 35128, Italy

Location

Vall d'Hebron University Hospital

Barcelona, 08035, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

CSF, plasma

MeSH Terms

Conditions

Cerebrovascular TraumaCraniocerebral Trauma

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemVascular DiseasesCardiovascular DiseasesWounds and Injuries

Study Officials

  • John Ward, MD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2007

First Posted

July 10, 2007

Study Start

July 1, 2007

Primary Completion

June 1, 2009

Study Completion

December 1, 2009

Last Updated

November 16, 2011

Record last verified: 2011-11

Locations

IT(1)ES(1)DE(1)US(8)