MedDataX Logo

Transcranial Doppler Measurement and Prognosis in Moderate Head Injury

NCT ID: NCT00353444

Last Updated: 2008-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

SUSPENDED

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The head injury is a frequent problem of health, which produces high morbi-mortality. Today is the main cause of death and disability between 18 and 40 years. In addition it originates expensive expenses in health care systems.

Severity of cerebral injury is not only because of impact, it is implicated many physiopathological changes. Decrease or increase of cerebral blood flow (CBF) play important roll formation of edema and intracranial hypertension. Hypoxic/ischemic damage is the final point of both changes.

The transcranial Doppler (TCD) was introduced around 1982. Through TCD can be measured the flow velocity of intracranial arteries, which let us identify changes in diameter in vessels. There are three windows of access to arteries: transtemporal, transorbitary and suboccipital.

The parameter are systolic velocity (S), tele-diastolic velocity (D), mean velocity (M) and pulsatility index (PI). Many studies have been conducted for evaluate utility in head injury, TCD can identify changes that correlate with alteration in CBF intracranial pressure (ICP).

The autoregulatory status is important, TCD with decrement in D and increment in PI could tell us about failure in this issue. An invasive way for estimate cerebral perfusion pressure (CCP) with TCD. The most sensible for fall in is amplitude in FV. However there is more correlation between CPP and PI. Vasospasm can occur post trauma, for identify the Lindegaard ratio (FVcma/FVcia) is useful. The other change, hyperemia, can be demonstrated by continuously increase FV. In post traumatic time is very important identify alterations which could produce ischemia. The measurement of CPP generally is gotten by invasión with ICP determination.

In severe head injury has been demonstrated correlation between ICP and PI, strongest for CPP and PI. Other parameters are oligaemia and vasospasm in the first 24 hours correlate poor outcome.

Because of the non invasive characteristic and good correlation with physiologic and prognosis, we think it is important evaluate if there are a kind of correlation between amnesia and orientation, prognosis and TCD parameters.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Head Injury

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

head injury transcranial Doppler pulsatility index vasospasm in head injury

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

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

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidad Autonoma de San Luis Potosí

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Torres-Corzo Jaime, Neurosurgeon

Role: PRINCIPAL_INVESTIGATOR

Hospital Central "Dr. Ignacio Morones Prieto"

Tapia-Perez Humberto, MD

Role: PRINCIPAL_INVESTIGATOR

Facultad de Medicina UASLP

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Central "Dr. Ignacio Morones Prieto"

San Luis Potosí City, San Luis Potosí, Mexico

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Mexico

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

27-07TCDHI

Identifier Type: -

Identifier Source: org_study_id