Severe Traumatic Brain Injury Clinical Trial
— ADAPTOfficial title:
Approaches and Decisions for Acute Pediatric TBI (ADAPT) Trial
Verified date | March 2023 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 brain injury. Pediatric traumatic brain injury (TBI) is the leading killer of children, resulting in more than 7000 deaths and $2 billion in acute care costs each year. Despite this large burden of disease, advances in the field have been limited due to weak evidenced-based guidelines and the limitations of randomized, controlled trials (RCTs) to demonstrate efficacy of single treatment strategies due to wide treatment variability. ADAPT is a practical study design in a novel approach - an observational cohort study designed to evaluate the association of 6 aspects of pediatric TBI care with outcomes using statistical modeling to correct for confounding variables. Completion of this study will provide compelling evidence to change clinical practices, provide evidence for new Level II recommendations for future guidelines and lead to improved research protocols that would limit variability in TBI treatments - helping children immediately through better clinical practices and ultimately through more effective investigation.
Status | Completed |
Enrollment | 1000 |
Est. completion date | August 28, 2018 |
Est. primary completion date | September 26, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 18 Years |
Eligibility | Inclusion Criteria: - 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 Criteria: - 1. ICP Monitor placed at another hospital - 2. Diagnosis of pregnancy in clinical subject |
Country | Name | City | State |
---|---|---|---|
Australia | Children's Health Queensland Hospital and Health Service | Brisbane | |
Australia | Royal Children's Hospital | Melbourne | |
Australia | Princess Margaret Hospital | Perth | |
India | All India Institute of Medical Sciences | New Delhi | |
Netherlands | Erasmus Medical Center Children's Hospital | Rotterdam | |
New Zealand | Starship Children's Hospital | Auckland | |
South Africa | University of Cape Town | Cape Town | |
Spain | Hospital Vall d'Hebron | Barcelona | |
United Kingdom | Birmingham Children's Hospita | Birmingham | |
United Kingdom | University Hospitals Bristol | Bristol | |
United Kingdom | Addenbrookes Hospital | Cambridge | |
United Kingdom | Leeds Teaching Hospital | Leeds | |
United Kingdom | Alder Hey Children's | Liverpool | |
United Kingdom | Great Ormond Street | London | |
United Kingdom | King's College Hospital | London | |
United Kingdom | Newcastle upon Tyne Hospital | Newcastle upon Tyne | |
United Kingdom | University Hospital Southampton | Southampton | |
United Kingdom | Royal Manchester Children's Hospital | Victoria | |
United States | Children's Healthcare of Atlanta | Atlanta | Georgia |
United States | John Hopkins Children's Center of Baltimore | Baltimore | Maryland |
United States | Children's Hospital of Alabama | Birmingham | Alabama |
United States | Boston Children's Hospital / Harvard University | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Carolinas Medical Center Levine Children's Hospital | Charlotte | North Carolina |
United States | University of Cincinnati / Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | Nationwide Children's Hospital | Columbus | Ohio |
United States | UT Southwestern / Children's Medical Center at Dallas | Dallas | Texas |
United States | Children's Hospital Colorado | Denver | Colorado |
United States | Wayne State University in Detroit / Children's Hospital of Michigan | Detroit | Michigan |
United States | Penn State University - Hershey | Hershey | Pennsylvania |
United States | Texas Children's Hospital (Baylor College of Medicine) | Houston | Texas |
United States | University of Iowa Children's Hospita | Iowa City | Iowa |
United States | University of California, San Diego / Rady's Children's Hospital | La Jolla | California |
United States | Children's Hospital of Los Angeles | Los Angeles | California |
United States | UCLA Mattel Children's Hospital | Los Angeles | California |
United States | University of Wisconsin - Madison | Madison | Wisconsin |
United States | University of Tennessee / Le Bonheur Children's Hospita | Memphis | Tennessee |
United States | Miami Children's Hospital | Miami | Florida |
United States | University of Nebraska Medical Center | Omaha | Nebraska |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Phoenix Children's Hospital | Phoenix | Arizona |
United States | Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania |
United States | Children's Hospital of Richmond at VCU | Richmond | Virginia |
United States | Washington University - St. Louis | Saint Louis | Missouri |
United States | Primary Children's Hospital | Salt Lake City | Utah |
United States | University of Washington - Seattle | Seattle | Washington |
United States | Children's National Medical Center | Washington | District of Columbia |
United States | UC Davis Medical Center | West Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | National Institute of Neurological Disorders and Stroke (NINDS) |
United States, Australia, India, Netherlands, New Zealand, South Africa, Spain, United Kingdom,
Bell MJ, Adelson PD, Wisniewski SR; Investigators of the ADAPT Study,. Challenges and opportunities for pediatric severe TBI-review of the evidence and exploring a way forward. Childs Nerv Syst. 2017 Oct;33(10):1663-1667. doi: 10.1007/s00381-017-3530-y. Epub 2017 Sep 6. — View Citation
Larsen GY, Schober M, Fabio A, Wisniewski SR, Grant MJ, Shafi N, Bennett TD, Hirtz D, Bell MJ. Structure, Process, and Culture Differences of Pediatric Trauma Centers Participating in an International Comparative Effectiveness Study of Children with Severe Traumatic Brain Injury. Neurocrit Care. 2016 Jun;24(3):353-60. doi: 10.1007/s12028-015-0218-6. — View Citation
Miller Ferguson N, Sarnaik A, Miles D, Shafi N, Peters MJ, Truemper E, Vavilala MS, Bell MJ, Wisniewski SR, Luther JF, Hartman AL, Kochanek PM; Investigators of the Approaches and Decisions in Acute Pediatric Traumatic Brain Injury (ADAPT) Trial. Abusive Head Trauma and Mortality-An Analysis From an International Comparative Effectiveness Study of Children With Severe Traumatic Brain Injury. Crit Care Med. 2017 Aug;45(8):1398-1407. doi: 10.1097/CCM.0000000000002378. — View Citation
Sarnaik A, Ferguson NM, O'Meara AMI, Agrawal S, Deep A, Buttram S, Bell MJ, Wisniewski SR, Luther JF, Hartman AL, Vavilala MS; Investigators of the ADAPT Trial. Age and Mortality in Pediatric Severe Traumatic Brain Injury: Results from an International Study. Neurocrit Care. 2018 Jun;28(3):302-313. doi: 10.1007/s12028-017-0480-x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Glasgow Outcome Score - Extended Pediatrics | Physician-rated assessment of functional outcome. Problems in functioning should have deteriorated from premorbid level. The categories are:
8 - Death 7 - Vegetative State (VS) 6 - Lower Severe Disability (Lower SD) 5 - Upper Severe Disability (Upper SD) 4 - Lower Moderate Disability (Lower MD) 3 - Upper Moderate Disability (Upper MD) 2 - Lower Good Recovery (Lower GR) 1 - Upper Good Recovery (Upper GR) |
6 months |
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