Transcranial Doppler Measurement and Prognosis in Moderate Head Injury

Head Injury Clinical Trial

Official title:

Transcranial Doppler Measurement and Prognosis in Moderate Head Injury

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00353444
• Other study ID #: 27-07TCDHI
• Status: Suspended
• Phase: Phase 2/Phase 3
• First received: July 17, 2006
• Last updated: November 5, 2008
• Start date: December 2006
• Est. completion date: March 2007

Study information

• Verified date: November 2008
• Source: Universidad Autonoma de San Luis Potosí
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: National Institute of Public Health, Health Secretariat
• Study type: Observational

Clinical Trial 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

Description:

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 70
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 50 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Craniocerebral Trauma
• Head Injury

Locations

Country	Name	City	State
Mexico	Hospital Central "Dr. Ignacio Morones Prieto"	San Luis Potosi

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de San Luis Potosí

Country where clinical trial is conducted

Mexico,