Brain InjuryPTBINCT01461902
Vasospasm in Pediatric Traumatic Brain Injury
An observational study of Brain Injury, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to assess for vasospasm using Transcranial Doppler (TCD) and brain injury biomarkers, and evaluate neurocognitive outcome data in pediatric traumatic brain injury (TBI) patients who have experienced a mild to severe head injury. Read more about this study
- Who is it for?
- Ages 5 days to 15 years
- Conditions the study is for
- Brain Injury
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Dec 2013
- 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 5 days to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients who have been admitted for a traumatic brain injury to Duke University Hospital.
Who may be able to join
- admission to Duke University Children's Hospital;
- age 5 days to 15 years;
- a diagnosis of a TBI with a GCS 3-15;
- capable of adequate TCD ultrasound examination;
- and presence of intravenous or arterial access (blood) and/or an EVD for cerebrospinal fluid (CSF) and/or Foley catheter/ability to void unassisted (urine) biomarker collection unless they are excluded based on the exclusion criteria.
Who cannot join
- the presence of previously diagnosed significant neurodevelopmental delay,
- a diagnosis of non-traumatic intracranial hemorrhage and
- parents/legal guardians who do not speak or understand English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University medical Center
Durham, North Carolina, 27710
About this study
Official title: Measuring Vasospasm, Biomarkers, and Neurocognitive Outcomes in Pediatric Traumatic Brain Injury
The purpose of this study is to assess for vasospasm using Transcranial Doppler (TCD) and brain injury biomarkers, and evaluate neurocognitive outcome data in pediatric traumatic brain injury (TBI) patients who have experienced a mild to severe head injury.
- Conditions
- Brain Injury
- Keywords
- traumatic brain injury, brain injury, head injury, vasospasm
- Medical subject headings
- Brain Injuries, Brain Injuries, Traumatic, Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Traumatic Brain Injury | Children from 5 days to 15 years of age who have been admitted to the hospital with a traumatic brain injury. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vasospasm detection by Transcranial Doppler Ultrasound
Daily transcranial doppler ultrasound performed in pediatric traumatic head injury patients.
Measured: 8 days
Secondary outcomes (1)
Detection of biomarkers in pediatric traumatic brain injury
Detection of a defined set of protein biomarkers from biological samples collected upon enrollment, 12, 24, and 48 hours.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2012
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuryStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karin Reuter-Rice, PhD, Principal investigator, Duke University School of Nursing and School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461902
- Sponsor's protocol ID
- Pro00027860
- Acronym
- PTBI
- Status last verified
- Jan 2015
- First submitted
- 26 Oct 2011
- Last updated
- 2 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Vasospasm, Biomarkers, and Neurocognitive Outcomes in Pediatric Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT01461902
- Acronym / sponsor ID
- PTBI / Pro00027860
- Conditions
- Brain Injury
- Keywords
- traumatic brain injury, brain injury, head injury, vasospasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 28 Oct 2011 (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 assess for vasospasm using Transcranial Doppler (TCD) and brain injury biomarkers, and evaluate neurocognitive outcome data in pediatric traumatic brain injury (TBI) patients who have experienced a mild to severe head injury.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Traumatic Brain Injury | – | –Children from 5 days to 15 years of age who have been admitted to the hospital with a traumatic brain injury. |
Who may qualify
- Ages
- 5 days to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients who have been admitted for a traumatic brain injury to Duke University Hospital.
Key inclusion criteria (5 listed)
- admission to Duke University Children's Hospital;
- age 5 days to 15 years;
- a diagnosis of a TBI with a GCS 3-15;
- capable of adequate TCD ultrasound examination;
- and presence of intravenous or arterial access (blood) and/or an EVD for cerebrospinal fluid (CSF) and/or Foley catheter/ability to void unassisted (urine) biomarker collection unless they are excluded based on the exclusion criteria.
Key exclusion criteria (3 listed)
- the presence of previously diagnosed significant neurodevelopmental delay,
- a diagnosis of non-traumatic intracranial hemorrhage and
- parents/legal guardians who do not speak or understand English.
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
Vasospasm detection by Transcranial Doppler Ultrasound
Time frame: 8 days
Daily transcranial doppler ultrasound performed in pediatric traumatic head injury patients.
1 secondary outcome
Detection of biomarkers in pediatric traumatic brain injury
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2015.
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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.
Karin Reuter-Rice, PhD principal investigator
Duke University School of Nursing and School of Medicine
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 Brain Injury, run by Duke University at 1 site in United States.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 2 Feb 2015. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Vasospasm detection by Transcranial Doppler Ultrasound (time frame: 8 days). It is what the study was designed to measure, not a finding.
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 2 Feb 2015.