Severe Traumatic Brain InjuryADAPTNCT04077411
Approaches and Decisions for Acute Pediatric TBI Trial
An observational study of Severe Traumatic Brain Injury, run by University of Pittsburgh at 48 sites in 8 countries.
Trial 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 brain injury. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Severe Traumatic Brain Injury
- What is being tested?
- Observational
- How many people
- 1,000 participants
- Where
- 48 sitesin 8 countries
- Study dates
- 20 Feb 2014to 28 Aug 2018
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children with severe traumatic brain injury (TBI)
Who may be able to join
- 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
Who cannot join
- 1. ICP Monitor placed at another hospital
- 2. Diagnosis of pregnancy in clinical subject
Trial locations and contacts
48 sites in 8 countries.
48 sites in 8 countries
United States30 sites
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
John Hopkins Children's Center of Baltimore
Baltimore, Maryland, 21287
Children's Hospital of Alabama
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02241
Boston Children's Hospital / Harvard University
Boston, Massachusetts, 414413
Carolinas Medical Center Levine Children's Hospital
Charlotte, North Carolina, 28260
University of Cincinnati / Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Nationwide Children's Hospital
Columbus, Ohio, 43271
UT Southwestern / Children's Medical Center at Dallas
Dallas, Texas, 75284
Children's Hospital Colorado
Denver, Colorado, 80045
Wayne State University in Detroit / Children's Hospital of Michigan
Detroit, Michigan, 13201
Penn State University - Hershey
Hershey, Pennsylvania, 17033
Texas Children's Hospital (Baylor College of Medicine)
Houston, Texas, 77030
University of Iowa Children's Hospita
Iowa City, Iowa, 52252
University of California, San Diego / Rady's Children's Hospital
La Jolla, California, 92093
Children's Hospital of Los Angeles
Los Angeles, California, 90027
UCLA Mattel Children's Hospital
Los Angeles, California, 90095
University of Wisconsin - Madison
Madison, Wisconsin, 53715
University of Tennessee / Le Bonheur Children's Hospita
Memphis, Tennessee, 38163
Miami Children's Hospital
Miami, Florida, 33155
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19178
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15213
Children's Hospital of Richmond at VCU
Richmond, Virginia, 23298
Primary Children's Hospital
Salt Lake City, Utah, 84113
University of Washington - Seattle
Seattle, Washington, 98185
Washington University - St. Louis
St Louis, Missouri, 63112
Children's National Medical Center
Washington D.C., District of Columbia, 20010
UC Davis Medical Center
West Sacramento, California, 95798
United Kingdom10 sites
Birmingham Children's Hospita
Birmingham, 6NH
University Hospitals Bristol
Bristol
Addenbrookes Hospital
Cambridge, CB2 0QQ
Leeds Teaching Hospital
Leeds, LS 7TF
Alder Hey Children's
Liverpool, L12 2AP
King's College Hospital
London, SE5 9NY
Great Ormond Street
London, WC1N 1EH
Newcastle upon Tyne Hospital
Newcastle upon Tyne, NE7 7DN
University Hospital Southampton
Southampton, SO16 6YD
Royal Manchester Children's Hospital
Victoria, 3052
Australia3 sites
Children's Health Queensland Hospital and Health Service
Brisbane
Royal Children's Hospital
Melbourne
Princess Margaret Hospital
Perth, 6008
Netherlands1 site
Erasmus Medical Center Children's Hospital
Rotterdam, 3015 GJ
About this study
Official title: Approaches and Decisions for Acute Pediatric TBI (ADAPT) Trial
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.
Read the 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. Based on the current best estimates for severe pediatric TBI (20% mortality, 50.6% unfavorable 6 mo outcome, mean age 9 y), each year 37,200 children suffer a severe TBI with up to 1.3 million life-years potentially adversely affected.
Incremental improvement in outcomes could make enormous differences for the health of children, but such advances have remained elusive. Dozens of injury mechanisms have been identified after experimental TBI, yet no mitigating treatments have been translated into clinical practice. Randomized controlled trials (RCTs) of therapies, from steroids to novel pharmaceutical agents to hypothermia, have failed for adult and pediatric TBI victims. Single-center experiences have contributed to understanding, yet these largely remain insufficiently powerful to change practice. Recently, evidenced-based guidelines for 15 aspects of pediatric TBI were published that provide no level I and only 4 Level II recommendations - with such recommendations indicating therapies that "must be done" or "should be considered" based on the literature, respectively. Disappointingly, 3 of these recommendations advised against specific interventions (hypothermia, steroids and immune-enhanced diets) - emphasizing the uncertainty of the effectiveness of many commonly used therapies that leads to wide variations in clinical practice. Unsurprisingly, significant variations of clinical outcomes and basic treatment strategies for TBI have been observed. The IMPACT study merged data from over 9000 adults with TBI from 11 trials and demonstrated significant variations in outcomes from clinical sites. Similar variations in outcomes in children with TBI can be found using various administrative databases, with mortality rates varying between 12.2% - 34.4% in 11 US states. There are also variations in strategies within an international consortium and a recently completed RCT - with marked variations in strategies for first-line intracranial hypertension treatments, prevention of common secondary insults and metabolic support after pediatric TBI.
The paucity of data to create robust guidelines, the failure of RCTs that tested a wide-variety of putative mechanisms and variations in outcomes and in clinical practices argues that the current understanding of contemporary therapies is inadequate. Because neither retrospective analyses from available databases nor self-reported variations in practices can determine optimal therapeutic strategies for these contemporaneous strategies, a new approach is urgently needed.
ADAPT is a large, prospective, observational cohort study using an international consortium including sites from the US, EU and UK. Children with severe TBI [Glasgow coma scale (GCS) score ≤ 8 with intracranial pressure (ICP) monitoring, n = 1000, >32 sites] will be studied. The local standard of care at each site will be used and extensive data collection over the first 7 days after TBI will be performed to interrogate the effectiveness of strategies for intracranial hypertension, mitigation of specific secondary insults and metabolism.
Several statistical approaches, often used in comparative effectiveness research (CER) to control for measured confounding effects, will test the following aims:
Specific Aim 1: Compare the effectiveness of first-line intracranial hypertension strategies on outcome. Intracranial hypertension management is a mainstay of TBI care yet evidence for utilization the first-line therapies of cerebrospinal fluid (CSF) diversion and use of hyperosmolar solutions, is incomplete.
Aim 1a: Determine the effect of CSF diversion strategies (continuous drainage, intermittent drainage and none) on outcome. Aim 1b: Determine the effect of hyperosmolar therapies (hypertonic saline, mannitol) on outcome.
Specific Aim 2: Compare the effectiveness of strategies that mitigate specific secondary insults on outcome. Prophylactic hyperventilation (HV) and hypoxia may worsen outcome after TBI but have been inadequately studied.
Aim 2a: Determine the effect of prophylactic HV (CO2 < 30 mm Hg) on outcome.
Aim 2b: Determine the effect of hypoxia detection with brain tissue oxygen monitoring (PbO2) on outcome.
- Conditions
- Severe Traumatic Brain Injury
- Being tested
- Observational
- Keywords
- Severe Traumatic Brain Injury, TBI, Intracranial hypertension, Cerebrospinal fluid, Hypersmolar therapies, Prophylactic hyperventilation, Metabolism, Neuropsychology
- Medical subject headings
- Brain Injuries, Traumatic, Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
This is an observational study with no interventions.
| Study group | Role | What they receive |
|---|---|---|
| Children with severe TBI | Children with severe Traumatic Brain Injury Receives: Other: Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start20 Feb 2014
- Primary completion26 Sep 2016
- Study completion28 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Severe Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephen Wisniewski, University of Pittsburgh
- Investigators
- Michael J Bell, MD, Principal investigator, University of Pittsburgh Medical CenterStephen R Wisniewski, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077411
- Sponsor's protocol ID
- PRO13020047
- Other IDs
- U01NS081041
- Acronym
- ADAPT
- Status last verified
- Mar 2023
- First submitted
- 29 Aug 2019
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data will be released to the general public through FITBIR. ADAPT will adhere to all FITBIR policies and procedures.
Publications
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.
PubMed 29476389Bell 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.
PubMed 29149394Miller 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.
PubMed 28430697Larsen 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.
PubMed 26627225Schopman LE, Land ME, Rakkar J, Appavu BL, Buttram SDW. Do Racial and Ethnic Disparities Exist in Intensity of Intracranial Pressure-Directed Therapies and Outcomes Following Pediatric Severe Traumatic Brain Injury? J Child Neurol. 2024 Jun;39(7-8):275-284. doi: 10.1177/08830738241269128. Epub 2024 Sep 9.
PubMed 39246040Ahmed N, Russo L, Kuo YH. Levetiracetam or Phenytoin as Prophylaxis for Status Epilepticus: Secondary Analysis of the "Approaches and Decisions in Acute Pediatric Traumatic Brain Injury Trial" (ADAPT) Dataset, 2014-2017. Pediatr Crit Care Med. 2024 Aug 1;25(8):710-719. doi: 10.1097/PCC.0000000000003526. Epub 2024 May 8.
PubMed 38717237Surtees TL, Kumar I, Garton HJL, Rivas-Rodriguez F, Parmar H, McCaffery H, Riebe-Rodgers J, Shellhaas RA. Levetiracetam Prophylaxis for Children Admitted With Traumatic Brain Injury. Pediatr Neurol. 2022 Jan;126:114-119. doi: 10.1016/j.pediatrneurol.2021.10.009. Epub 2021 Oct 19.
PubMed 34839268
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Approaches and Decisions for Acute Pediatric TBI (ADAPT) Trial
- ClinicalTrials.gov ID
- NCT04077411
- Acronym / sponsor ID
- ADAPT / PRO13020047
- Conditions
- Severe Traumatic Brain Injury
- Keywords
- Severe Traumatic Brain Injury, TBI, Intracranial hypertension, Cerebrospinal fluid, Hypersmolar therapies, Prophylactic hyperventilation, Metabolism, Neuropsychology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 20 Feb 2014 (actual)
- Primary completion
- 26 Sep 2016 (actual)
- Study completion
- 28 Aug 2018 (actual)
- First posted
- 4 Sep 2019 (actual)
- 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.
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.
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. Based on the current best estimates for severe pediatric TBI (20% mortality, 50.6% unfavorable 6 mo outcome, mean age 9 y), each year 37,200 children suffer a severe TBI with up to 1.3 million life-years potentially adversely affected.
Incremental improvement in outcomes could make enormous differences for the health of children, but such advances have remained elusive. Dozens of injury mechanisms have been identified after experimental TBI, yet no mitigating treatments have been translated into clinical practice. Randomized controlled trials (RCTs) of therapies, from steroids to novel pharmaceutical agents to hypothermia, have failed for adult and pediatric TBI victims. Single-center experiences have contributed to understanding, yet these largely remain insufficiently powerful to change practice. Recently, evidenced-based guidelines for 15 aspects of pediatric TBI were published that provide no level I and only 4 Level II recommendations - with such recommendations indicating therapies that "must be done" or "should be considered" based on the literature, respectively. Disappointingly, 3 of these recommendations advised against specific interventions (hypothermia, steroids and immune-enhanced diets) - emphasizing the uncertainty of the effectiveness of many commonly used therapies that leads to wide variations in clinical practice. Unsurprisingly, significant variations of clinical outcomes and basic treatment strategies for TBI have been observed. The IMPACT study merged data from over 9000 adults with TBI from 11 trials and demonstrated significant variations in outcomes from clinical sites. Similar variations in outcomes in children with TBI can be found using various administrative databases, with mortality rates varying between 12.2% - 34.4% in 11 US states. There are also variations in strategies within an international consortium and a recently completed RCT - with marked variations in strategies for first-line intracranial hypertension treatments, prevention of common secondary insults and metabolic support after pediatric TBI.
The paucity of data to create robust guidelines, the failure of RCTs that tested a wide-variety of putative mechanisms and variations in outcomes and in clinical practices argues that the current understanding of contemporary therapies is inadequate. Because neither retrospective analyses from available databases nor self-reported variations in practices can determine optimal therapeutic strategies for these contemporaneous strategies, a new approach is urgently needed.
ADAPT is a large, prospective, observational cohort study using an international consortium including sites from the US, EU and UK. Children with severe TBI [Glasgow coma scale (GCS) score ≤ 8 with intracranial pressure (ICP) monitoring, n = 1000, >32 sites] will be studied. The local standard of care at each site will be used and extensive data collection over the first 7 days after TBI will be performed to interrogate the effectiveness of strategies for intracranial hypertension, mitigation of specific secondary insults and metabolism.
Several statistical approaches, often used in comparative effectiveness research (CER) to control for measured confounding effects, will test the following aims:
Specific Aim 1: Compare the effectiveness of first-line intracranial hypertension strategies on outcome. Intracranial hypertension management is a mainstay of TBI care yet evidence for utilization the first-line therapies of cerebrospinal fluid (CSF) diversion and use of hyperosmolar solutions, is incomplete.
Aim 1a: Determine the effect of CSF diversion strategies (continuous drainage, intermittent drainage and none) on outcome. Aim 1b: Determine the effect of hyperosmolar therapies (hypertonic saline, mannitol) on outcome.
Specific Aim 2: Compare the effectiveness of strategies that mitigate specific secondary insults on outcome. Prophylactic hyperventilation (HV) and hypoxia may worsen outcome after TBI but have been inadequately studied.
Aim 2a: Determine the effect of prophylactic HV (CO2 < 30 mm Hg) on outcome.
Aim 2b: Determine the effect of hypoxia detection with brain tissue oxygen monitoring (PbO2) on outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with severe TBI | – | Other: ObservationalChildren with severe Traumatic Brain Injury |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children with severe traumatic brain injury (TBI)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 1. ICP Monitor placed at another hospital
- 2. Diagnosis of pregnancy in clinical subject
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalThis is an observational study with no interventions. | Other | Children with severe TBI |
Primary outcome
Glasgow Outcome Score - Extended Pediatrics
Time frame: 6 months
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)
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 8 Dec 2023.
- Background: PubMed 29476389Sarnaik 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.
- Background: PubMed 29149394Bell 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.
- Background: PubMed 28430697Miller 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.
- Background: PubMed 26627225Larsen 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.
- Derived from this study: PubMed 39246040Schopman LE, Land ME, Rakkar J, Appavu BL, Buttram SDW. Do Racial and Ethnic Disparities Exist in Intensity of Intracranial Pressure-Directed Therapies and Outcomes Following Pediatric Severe Traumatic Brain Injury? J Child Neurol. 2024 Jun;39(7-8):275-284. doi: 10.1177/08830738241269128. Epub 2024 Sep 9.
- Derived from this study: PubMed 38717237Ahmed N, Russo L, Kuo YH. Levetiracetam or Phenytoin as Prophylaxis for Status Epilepticus: Secondary Analysis of the "Approaches and Decisions in Acute Pediatric Traumatic Brain Injury Trial" (ADAPT) Dataset, 2014-2017. Pediatr Crit Care Med. 2024 Aug 1;25(8):710-719. doi: 10.1097/PCC.0000000000003526. Epub 2024 May 8.
- Derived from this study: PubMed 34839268Surtees TL, Kumar I, Garton HJL, Rivas-Rodriguez F, Parmar H, McCaffery H, Riebe-Rodgers J, Shellhaas RA. Levetiracetam Prophylaxis for Children Admitted With Traumatic Brain Injury. Pediatr Neurol. 2022 Jan;126:114-119. doi: 10.1016/j.pediatrneurol.2021.10.009. Epub 2021 Oct 19.
- Individual participant dataSharing planned: Yes. Study data will be released to the general public through FITBIR. ADAPT will adhere to all FITBIR policies and procedures.
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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.
Michael J Bell, MD principal investigator
University of Pittsburgh Medical Center
Stephen R Wisniewski, PhD principal investigator
University of Pittsburgh
48 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Traumatic Brain Injury, run by University of Pittsburgh at 48 sites in 8 countries.
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 2 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 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, United Kingdom, Australia, India, Netherlands and 3 more countries. 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?
Glasgow Outcome Score - Extended Pediatrics (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04077411, which also lists 7 linked publications.
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 8 Dec 2023.