Clinical trial NCT00353444: Transcranial Doppler Measurement and Prognosis in Moderate Head Injury
Official title: Transcranial Doppler Measurement and Prognosis in Moderate Head Injury
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Head Injury
Keywords: head injury
transcranial Doppler
pulsatility index
vasospasm in head injury
Lead sponsor: Universidad Autonoma de San Luis Potosí
Sponsor class: OTHER
First posted: 2006-07-18
Enrollment: 70
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Luis Potosi
country: Mexico
facility: Hospital Central "Dr. Ignacio Morones Prieto"
Study officials:
affiliation: Hospital Central "Dr. Ignacio Morones Prieto"
name: Torres-Corzo Jaime, Neurosurgeon
role: PRINCIPAL_INVESTIGATOR
affiliation: Facultad de Medicina UASLP
name: Tapia-Perez Humberto, MD
role: PRINCIPAL_INVESTIGATOR
References: