NCT00353444

Brief Summary

The purpose of this study is to determine whether Transcranial Doppler measurements have correlation with neuropsychological test (Galvestone Orientation Amnesia Test), TC image (Marshall Scale) and prognosis (DRS and GOS) in moderate head injury

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
suspended

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

First Submitted

Initial submission to the registry

July 17, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 18, 2006

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

November 6, 2008

Status Verified

November 1, 2008

First QC Date

July 17, 2006

Last Update Submit

November 5, 2008

Conditions

Head Injury

Keywords

head injurytranscranial Dopplerpulsatility indexvasospasm in head injury

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Man or woman \>16 and \<50 years with HI less 24 hours in progression and Glasgow between 9 y 12.
  • Man or woman \>16 and \<50 years with HI and Glasgow l3, with lesions in TC scan.
  • TC scan.
  • Acceptance of family to participate (first grade).

You may not qualify if:

  • History of HI with disability
  • History of neurological or psychiatric disease with disability.
  • Existence of systemic injury with life in compromise (massive bleeding, exposition in fracture, hepatic or splenic laceration or in great vessels and shock).
  • Existence of intracranial lesion which needs surgery.
  • Cerebral death certificated by neurologist or neurosurgeon (EEG o arteriography).
  • Management previous in other Hospital.
  • Hemoglobin \< 10 g/L

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Central "Dr. Ignacio Morones Prieto"

San Luis Potosí City, San Luis Potosí, 78240, Mexico

Location

MeSH Terms

Conditions

Craniocerebral Trauma

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and Injuries

Study Officials

  • Torres-Corzo Jaime, Neurosurgeon

    Hospital Central "Dr. Ignacio Morones Prieto"

    PRINCIPAL INVESTIGATOR

  • Tapia-Perez Humberto, MD

    Facultad de Medicina UASLP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 17, 2006

First Posted

July 18, 2006

Study Start

December 1, 2006

Study Completion

March 1, 2007

Last Updated

November 6, 2008

Record last verified: 2008-11

Locations

ME(1)