- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00353444
Transcranial Doppler Measurement and Prognosis in Moderate Head Injury
Study Overview
Status
Conditions
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.
Study Type
Enrollment
Contacts and Locations
Study Locations
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San Luis Potosi, Mexico, 78240
- Hospital Central "Dr. Ignacio Morones Prieto"
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Investigators
- Principal Investigator: Torres-Corzo Jaime, Neurosurgeon, Hospital Central "Dr. Ignacio Morones Prieto"
- Principal Investigator: Tapia-Perez Humberto, MD, Facultad de Medicina UASLP
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 27-07TCDHI
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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