Vasospasm in Pediatric Traumatic Brain Injury (PTBI)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: October 26, 2011
Last updated: January 27, 2014
Last verified: December 2012
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Measuring Vasospasm, Biomarkers, and Neurocognitive Outcomes in Pediatric Traumatic Brain Injury
Primary Outcome Measures:
Secondary Outcome Measures:
- Detection of biomarkers in pediatric traumatic brain injury [ Time Frame: 2 days ] [ Designated as safety issue: No ]
Detection of a defined set of protein biomarkers from biological samples collected upon enrollment, 12, 24, and 48 hours.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Primary Completion Date:
||December 2013 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||up to 15 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Pediatric patients who have been admitted for a traumatic brain injury to Duke University Hospital.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01461902
|Duke University medical Center
|Durham, North Carolina, United States, 27710 |
||Karin Reuter-Rice, PhD
||Duke University School of Nursing and School of Medicine
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 26, 2011
||January 27, 2014
||United States: Institutional Review Board
Keywords provided by Duke University:
traumatic brain injury
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 24, 2014
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries