Status:
COMPLETED
Approaches and Decisions for Acute Pediatric TBI Trial
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Severe Traumatic Brain Injury
Eligibility:
All Genders
Up to 18 years
Brief Summary
Approaches and Decisions in Acute Pediatric TBI Trial (ADAPT) is an international research study designed to evaluate the impact of interventions on the outcomes of children with severe traumatic brai...
Detailed Description
Traumatic brain injury (TBI) is the leading cause of death in children in the US. According to the CDC, 7440 children died of TBI in 2005, but this likely underestimates the full burden of the disease...
Eligibility Criteria
Inclusion
- Admission to a study site for treatment of severe traumatic brain injury
- ICP monitor placed as part of the child's standard care
- Glasgow Coma Scale (GCS) ≤ 8 after resuscitation
- Age 0 - 18 y
Exclusion
- 1\. ICP Monitor placed at another hospital
- 2\. Diagnosis of pregnancy in clinical subject
Key Trial Info
Start Date :
February 20 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 28 2018
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04077411
Start Date
February 20 2014
End Date
August 28 2018
Last Update
December 8 2023
Active Locations (48)
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1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35294
2
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
3
University of California, San Diego / Rady's Children's Hospital
La Jolla, California, United States, 92093
4
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027