Head InjuryNCT00353444
Transcranial Doppler Measurement and Prognosis in Moderate Head Injury
An observational study of Head Injury, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
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 Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Head Injury
- How many people
- 70 participants
- Where
- 1 siteMexico
- Study dates
- Dec 2006to Mar 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Central "Dr. Ignacio Morones Prieto"
San Luis Potosí City, San Luis Potosí, 78240
About this study
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
Read the 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.
- Conditions
- Head Injury
- Keywords
- head injury, transcranial Doppler, pulsatility index, vasospasm in head injury
- Medical subject headings
- Craniocerebral Trauma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2006 (estimated)
- Study startDec 2006
- Study completionMar 2007
Why it stopped: Technical Conflicts
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- Universidad Autonoma de San Luis Potosí
- Sponsor type
- University, hospital or other
- Investigators
- Torres-Corzo Jaime, Neurosurgeon, Principal investigator, Hospital Central "Dr. Ignacio Morones Prieto"Tapia-Perez Humberto, MD, Principal investigator, Facultad de Medicina UASLP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00353444
- Sponsor's protocol ID
- 27-07TCDHI
- Status last verified
- Nov 2008
- First submitted
- 17 Jul 2006
- Last updated
- 6 Nov 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Doppler Measurement and Prognosis in Moderate Head Injury
- ClinicalTrials.gov ID
- NCT00353444
- Acronym / sponsor ID
- 27-07TCDHI
- Conditions
- Head Injury
- Keywords
- head injury, transcranial Doppler, pulsatility index, vasospasm in head injury
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Technical Conflicts
- Enrolment
- 70 participants
- Lead sponsor
- Universidad Autonoma de San Luis PotosíUniversity, hospital or other
- Study start
- Dec 2006
- Study completion
- Mar 2007
- First posted
- 18 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torres-Corzo Jaime, Neurosurgeon principal investigator
Hospital Central "Dr. Ignacio Morones Prieto"
Tapia-Perez Humberto, MD principal investigator
Facultad de Medicina UASLP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head Injury, run by Universidad Autonoma de San Luis Potosí at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 6 Nov 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2008.