Pediatric AllTRAPNCT03359421
Trauma Routing Algorithm for Pediatrics
An observational study of Pediatric All and Trauma, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Traumatic injury is the leading cause of pediatric death in the United States for those forty-four years of age and younger. Pediatric trauma patients generally have reduced mortality when treated at pediatric trauma centers rather than at adult centers or non-tertiary care facilities. Read more about this study
- Who is it for?
- Ages 2 days to 18 years
- Conditions the study is for
- Pediatric All, Trauma
- How many people
- 4,801 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2017to 31 May 2020
- How long will I take part?
- 1 Month
- 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 2 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients <16 years old involved in trauma that were transported to a North Carolina Trauma Center
Who may be able to join
- Pediatric trauma victims 0-16 years old who are reported in the North Carolina Trauma Registry after presenting to a North Carolina Trauma Center between January 1st, 2013 and October, 2017.
Who cannot join
- Interfacility transport patients are excluded
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27057
About this study
Traumatic injury is the leading cause of pediatric death in the United States for those forty-four years of age and younger. Pediatric trauma patients generally have reduced mortality when treated at pediatric trauma centers rather than at adult centers or non-tertiary care facilities. However, nearly half the US pediatric population lives over fifty miles from a Level I or II Trauma Center. While air ambulances are readily available in many jurisdictions, few guidelines and little evidence dictate their appropriate use, especially with regard to pediatric trauma. Previous research is mixed regarding mortality benefit from helicopter Emergency Medical Services (EMS) in injured children. Previous attempts to develop appropriate field triage criteria have failed due to poor sensitivity and specificity for identifying the critically injured child. The current high rate of overtriage is particularly concerning in today's cost-conscious medical community. This research study aims to categorize pre-hospital pediatric trauma in North Carolina, to determine what benefits helicopter EMS provides in the North Carolina trauma system, and to formulate an enhanced screening tool for pre-hospital use to help determine which patients are suitable candidates for helicopter EMS transport.
Read the detailed description
The North Carolina Trauma Registry will identify pediatric trauma patients between 0 and 18 years of age who presented directly to North Carolina Level 1 Trauma Centers from the field after sustaining injury from January 1st, 2013 and October 2017.
The analysis will be a retrospective cohort study by nature of the data set. Final methodology will be determined after Institutional Review Board approval and enlistment of statistical support through the Clinical and Translational Science Institute. Clinical and non-clinical factors will first be summarized with univariate analysis to provide a descriptive overview of the study population. These factors will include number of case-patients, demographics, scene address/location, time of injury, EMS agency involved, EMS call times, transport mechanism, time of transport, distance of transport, geographic area of injury, mechanism of injury, severity scores, Glasgow Coma Score, vital signs, receiving hospital name, and other variables. Similarly, interventions and outcomes will be compared between study groups through such factors such as length of emergency department stay, emergency department disposition, time to operating room, intubation status on arrival, administration of blood products, days of hospital stay, days of intensive care unit stay, days on ventilator, if viable organs were procured post-mortem, and mortality at given time points. Outcomes will be compared through regression analysis or related means.
- Conditions
- Pediatric All, Trauma
- Keywords
- prehospital, aeromedical, trauma, ems, helicopter
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Wounds and Injuries
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 |
|---|---|---|
| Aeromedical transport | Patients transported to trauma center by helicopter | |
| Ground transport | Patients transported to trauma center by ground ambulance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Patient survival
Measured: approximately 1 month or less
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2017
- Study start27 Nov 2017
- Primary completion15 Dec 2017
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Pediatric AllStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 4,801 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Stopyra, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03359421
- Sponsor's protocol ID
- IRB00047353
- Acronym
- TRAP
- Status last verified
- Dec 2021
- First submitted
- 27 Nov 2017
- Last updated
- 10 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arfken CL, Shapiro MJ, Bessey PQ, Littenberg B. Effectiveness of helicopter versus ground ambulance services for interfacility transport. J Trauma. 1998 Oct;45(4):785-90. doi: 10.1097/00005373-199810000-00031.
PubMed 9783622Baxt WG, Moody P. The impact of a rotorcraft aeromedical emergency care service on trauma mortality. JAMA. 1983 Jun 10;249(22):3047-51.
PubMed 6854826Biewener A, Aschenbrenner U, Rammelt S, Grass R, Zwipp H. Impact of helicopter transport and hospital level on mortality of polytrauma patients. J Trauma. 2004 Jan;56(1):94-8. doi: 10.1097/01.TA.0000061883.92194.50.
PubMed 14749573Bledsoe BE, Wesley AK, Eckstein M, Dunn TM, O'Keefe MF. Helicopter scene transport of trauma patients with nonlife-threatening injuries: a meta-analysis. J Trauma. 2006 Jun;60(6):1257-65; discussion 1265-6. doi: 10.1097/01.ta.0000196489.19928.c0.
PubMed 16766969Chappell VL, Mileski WJ, Wolf SE, Gore DC. Impact of discontinuing a hospital-based air ambulance service on trauma patient outcomes. J Trauma. 2002 Mar;52(3):486-91. doi: 10.1097/00005373-200203000-00012.
PubMed 11901324Englum BR, Rialon KL, Kim J, Shapiro ML, Scarborough JE, Rice HE, Adibe OO, Tracy ET. Current use and outcomes of helicopter transport in pediatric trauma: a review of 18,291 transports. J Pediatr Surg. 2017 Jan;52(1):140-144. doi: 10.1016/j.jpedsurg.2016.10.030. Epub 2016 Oct 27.
PubMed 27852453Floccare DJ, Stuhlmiller DF, Braithwaite SA, Thomas SH, Madden JF, Hankins DG, Dhindsa H, Millin MG. Appropriate and safe utilization of helicopter emergency medical services: a joint position statement with resource document. Prehosp Emerg Care. 2013 Oct-Dec;17(4):521-5. doi: 10.3109/10903127.2013.804139. Epub 2013 Jul 8.
PubMed 23834231Lerner EB, Drendel AL, Cushman JT, Badawy M, Shah MN, Guse CE, Cooper A. Ability of the Physiologic Criteria of the Field Triage Guidelines to Identify Children Who Need the Resources of a Trauma Center. Prehosp Emerg Care. 2017 Mar-Apr;21(2):180-184. doi: 10.1080/10903127.2016.1233311. Epub 2016 Oct 6.
PubMed 27710155Michailidou M, Goldstein SD, Salazar J, Aboagye J, Stewart D, Efron D, Abdullah F, Haut ER. Helicopter overtriage in pediatric trauma. J Pediatr Surg. 2014 Nov;49(11):1673-7. doi: 10.1016/j.jpedsurg.2014.08.008. Epub 2014 Nov 6.
PubMed 25475816Mitchell AD, Tallon JM, Sealy B. Air versus ground transport of major trauma patients to a tertiary trauma centre: a province-wide comparison using TRISS analysis. Can J Surg. 2007 Apr;50(2):129-33.
PubMed 17550717Moront ML, Gotschall CS, Eichelberger MR. Helicopter transport of injured children: system effectiveness and triage criteria. J Pediatr Surg. 1996 Aug;31(8):1183-6; discussion 1187-8. doi: 10.1016/s0022-3468(96)90114-1.
PubMed 8863261Potoka DA, Schall LC, Gardner MJ, Stafford PW, Peitzman AB, Ford HR. Impact of pediatric trauma centers on mortality in a statewide system. J Trauma. 2000 Aug;49(2):237-45. doi: 10.1097/00005373-200008000-00009.
PubMed 10963534Sathya C, Alali AS, Wales PW, Scales DC, Karanicolas PJ, Burd RS, Nance ML, Xiong W, Nathens AB. Mortality Among Injured Children Treated at Different Trauma Center Types. JAMA Surg. 2015 Sep;150(9):874-81. doi: 10.1001/jamasurg.2015.1121.
PubMed 26106848Stewart CL, Metzger RR, Pyle L, Darmofal J, Scaife E, Moulton SL. Helicopter versus ground emergency medical services for the transportation of traumatically injured children. J Pediatr Surg. 2015 Feb;50(2):347-52. doi: 10.1016/j.jpedsurg.2014.09.040. Epub 2014 Oct 1.
PubMed 25638635Sullivent EE, Faul M, Wald MM. Reduced mortality in injured adults transported by helicopter emergency medical services. Prehosp Emerg Care. 2011 Jul-Sep;15(3):295-302. doi: 10.3109/10903127.2011.569849. Epub 2011 Apr 27.
PubMed 21524205
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trauma Routing Algorithm for Pediatrics
- ClinicalTrials.gov ID
- NCT03359421
- Acronym / sponsor ID
- TRAP / IRB00047353
- Conditions
- Pediatric All, Trauma
- Keywords
- prehospital, aeromedical, trauma, ems, helicopter
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,801 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 27 Nov 2017 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 2 Dec 2017 (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.
Traumatic injury is the leading cause of pediatric death in the United States for those forty-four years of age and younger. Pediatric trauma patients generally have reduced mortality when treated at pediatric trauma centers rather than at adult centers or non-tertiary care facilities. However, nearly half the US pediatric population lives over fifty miles from a Level I or II Trauma Center. While air ambulances are readily available in many jurisdictions, few guidelines and little evidence dictate their appropriate use, especially with regard to pediatric trauma. Previous research is mixed regarding mortality benefit from helicopter Emergency Medical Services (EMS) in injured children. Previous attempts to develop appropriate field triage criteria have failed due to poor sensitivity and specificity for identifying the critically injured child. The current high rate of overtriage is particularly concerning in today's cost-conscious medical community. This research study aims to categorize pre-hospital pediatric trauma in North Carolina, to determine what benefits helicopter EMS provides in the North Carolina trauma system, and to formulate an enhanced screening tool for pre-hospital use to help determine which patients are suitable candidates for helicopter EMS transport.
Detailed description
The North Carolina Trauma Registry will identify pediatric trauma patients between 0 and 18 years of age who presented directly to North Carolina Level 1 Trauma Centers from the field after sustaining injury from January 1st, 2013 and October 2017.
The analysis will be a retrospective cohort study by nature of the data set. Final methodology will be determined after Institutional Review Board approval and enlistment of statistical support through the Clinical and Translational Science Institute. Clinical and non-clinical factors will first be summarized with univariate analysis to provide a descriptive overview of the study population. These factors will include number of case-patients, demographics, scene address/location, time of injury, EMS agency involved, EMS call times, transport mechanism, time of transport, distance of transport, geographic area of injury, mechanism of injury, severity scores, Glasgow Coma Score, vital signs, receiving hospital name, and other variables. Similarly, interventions and outcomes will be compared between study groups through such factors such as length of emergency department stay, emergency department disposition, time to operating room, intubation status on arrival, administration of blood products, days of hospital stay, days of intensive care unit stay, days on ventilator, if viable organs were procured post-mortem, and mortality at given time points. Outcomes will be compared through regression analysis or related means.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aeromedical transport | – | –Patients transported to trauma center by helicopter |
| Ground transport | – | –Patients transported to trauma center by ground ambulance |
Who may qualify
- Ages
- 2 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients <16 years old involved in trauma that were transported to a North Carolina Trauma Center
Key inclusion criteria (1 listed)
- Pediatric trauma victims 0-16 years old who are reported in the North Carolina Trauma Registry after presenting to a North Carolina Trauma Center between January 1st, 2013 and October, 2017.
Key exclusion criteria (1 listed)
- Interfacility transport patients are excluded
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
Survival
Time frame: approximately 1 month or less
Patient survival
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 10 Dec 2021.
- Background: PubMed 9783622Arfken CL, Shapiro MJ, Bessey PQ, Littenberg B. Effectiveness of helicopter versus ground ambulance services for interfacility transport. J Trauma. 1998 Oct;45(4):785-90. doi: 10.1097/00005373-199810000-00031.
- Background: PubMed 6854826Baxt WG, Moody P. The impact of a rotorcraft aeromedical emergency care service on trauma mortality. JAMA. 1983 Jun 10;249(22):3047-51.
- Background: PubMed 14749573Biewener A, Aschenbrenner U, Rammelt S, Grass R, Zwipp H. Impact of helicopter transport and hospital level on mortality of polytrauma patients. J Trauma. 2004 Jan;56(1):94-8. doi: 10.1097/01.TA.0000061883.92194.50.
- Background: PubMed 16766969Bledsoe BE, Wesley AK, Eckstein M, Dunn TM, O'Keefe MF. Helicopter scene transport of trauma patients with nonlife-threatening injuries: a meta-analysis. J Trauma. 2006 Jun;60(6):1257-65; discussion 1265-6. doi: 10.1097/01.ta.0000196489.19928.c0.
- Background: PubMed 11901324Chappell VL, Mileski WJ, Wolf SE, Gore DC. Impact of discontinuing a hospital-based air ambulance service on trauma patient outcomes. J Trauma. 2002 Mar;52(3):486-91. doi: 10.1097/00005373-200203000-00012.
- Background: PubMed 27852453Englum BR, Rialon KL, Kim J, Shapiro ML, Scarborough JE, Rice HE, Adibe OO, Tracy ET. Current use and outcomes of helicopter transport in pediatric trauma: a review of 18,291 transports. J Pediatr Surg. 2017 Jan;52(1):140-144. doi: 10.1016/j.jpedsurg.2016.10.030. Epub 2016 Oct 27.
- Background: PubMed 23834231Floccare DJ, Stuhlmiller DF, Braithwaite SA, Thomas SH, Madden JF, Hankins DG, Dhindsa H, Millin MG. Appropriate and safe utilization of helicopter emergency medical services: a joint position statement with resource document. Prehosp Emerg Care. 2013 Oct-Dec;17(4):521-5. doi: 10.3109/10903127.2013.804139. Epub 2013 Jul 8.
- Background: PubMed 27710155Lerner EB, Drendel AL, Cushman JT, Badawy M, Shah MN, Guse CE, Cooper A. Ability of the Physiologic Criteria of the Field Triage Guidelines to Identify Children Who Need the Resources of a Trauma Center. Prehosp Emerg Care. 2017 Mar-Apr;21(2):180-184. doi: 10.1080/10903127.2016.1233311. Epub 2016 Oct 6.
- Background: PubMed 25475816Michailidou M, Goldstein SD, Salazar J, Aboagye J, Stewart D, Efron D, Abdullah F, Haut ER. Helicopter overtriage in pediatric trauma. J Pediatr Surg. 2014 Nov;49(11):1673-7. doi: 10.1016/j.jpedsurg.2014.08.008. Epub 2014 Nov 6.
- Background: PubMed 17550717Mitchell AD, Tallon JM, Sealy B. Air versus ground transport of major trauma patients to a tertiary trauma centre: a province-wide comparison using TRISS analysis. Can J Surg. 2007 Apr;50(2):129-33.
- Background: PubMed 8863261Moront ML, Gotschall CS, Eichelberger MR. Helicopter transport of injured children: system effectiveness and triage criteria. J Pediatr Surg. 1996 Aug;31(8):1183-6; discussion 1187-8. doi: 10.1016/s0022-3468(96)90114-1.
- Background: PubMed 10963534Potoka DA, Schall LC, Gardner MJ, Stafford PW, Peitzman AB, Ford HR. Impact of pediatric trauma centers on mortality in a statewide system. J Trauma. 2000 Aug;49(2):237-45. doi: 10.1097/00005373-200008000-00009.
- Individual participant dataSharing planned: No
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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.
Jason Stopyra, MD principal investigator
Wake Forest University Health Sciences
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 Pediatric All and Trauma, run by Wake Forest University Health Sciences 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 1 inclusion and 1 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 10 Dec 2021. 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?
Survival (time frame: approximately 1 month or less). 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 NCT03359421, which also lists 16 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 10 Dec 2021.