NCT01339702

Brief Summary

Evaluation of the impact (on survival and other outcomes) of implementing the Brain Trauma Foundation/National Association of EMS Physicians Traumatic Brain Injury (TBI) guidelines in the prehospital EMS systems throughout the state of Arizona.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26,873

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 21, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 28, 2018

Status Verified

August 1, 2018

Enrollment Period

5.9 years

First QC Date

April 15, 2011

Last Update Submit

August 25, 2018

Conditions

Brain Injuries, TraumaticInjuries, Acute BrainTBI (Traumatic Brain Injury)

Keywords

Traumatic Brain InjuryTBIHead TraumaAcute Traumatic Brain InjuryTrauma, Brain

Outcome Measures

Primary Outcomes (1)

  • Survival

    Participants will be followed for the duration of hospital stay. The average time from admission to either discharge or death is expected to be approximately 3 weeks.

    hospital discharge

Secondary Outcomes (4)

  • hospital length of stay

    discharge from hospital

  • Intensive care unit length of stay

    admission to ICU to transfer from ICU

  • ventilator days

    during hospitalization

  • Patient disposition

    hospital discharge

Study Arms (2)

Pre-implementation cohort ("before")

This cohort is a combination of retrospective and some prospective severe TBI patients cared for in the EMS systems of Arizona BEFORE implementation of the national prehospital TBI management guidelines

Post-implementation cohort ("after")

This cohort is a comprised of prospective severe TBI patients cared for in the EMS systems of Arizona AFTER training EMS providers in the implementation of the national prehospital TBI management guidelines. It is intended that these patients will receive the "bundle" of care specified in the TBI Guidelines.

Other: The National Prehospital TBI Management Guidelines

Interventions

The National Prehospital TBI Management GuidelinesOTHER

In the post-implementation (after) cohort, implementation of the entire "bundle" of the TBI treatment guidelines with special emphasis on prevention and treatment of hypotension (IV crystalloids), prevention and treatment of hypoxia (pre-oxygenation with high-flow O2 via non-rebreather mask, bag-valve-mask, extraglottic airways/intubation when basic maneuvers have failed), and prevention of hyperventilation (in intubated patients) and prevention/treatment of hypoventilation (in all patients).

Also known as: Brain Trauma Foundation TBI Guidelines, National Association of EMS Physicians TBI Guidelines
Post-implementation cohort ("after")

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults and children of all ages with acute, moderate or severe TBI cared for in the participating EMS systems of Arizona who are taken to a Level 1 Trauma Center (either directly by EMS or transfered by EMS). This will include approximately 4 years of retrospective cases and 4.5 years of prospective cases.

You may qualify if:

  • Adults and children with physical trauma who: 1) are transported directly to or are transferred to a level I TC by participating EMS agencies, 2) have hospital diagnosis(es) consistent with TBI (either isolated or multisystem trauma that includes TBI), and 3) meet at least one of the following definitions for severe TBI: a) last prehospital GCS or first hospital/trauma center GCS \<9; b) AIS-head of ≥3, c) CDC Barell Matrix-Type 1, d) undergo prehospital ETI, nasal intubation, or cricothyrotomy.

You may not qualify if:

  • Patients with brain injury from: 1) non-mechanical mechanisms (e.g., drowning); 2) choking, primary asphyxiation, or strangulation; 3) environmental injury (e.g., hyperthermia); 4) poisoning (e.g., drug overdose, carbon monoxide, insecticides); 5) intracranial hemorrhage of non-traumatic origin; 6) other non-traumatic, acute neurological emergencies (e.g., bacterial meningitis).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona Emergency Medicine Research Center

Phoenix, Arizona, 85004, United States

Location

Related Publications (5)

  • Spaite DW, Bobrow BJ, Stolz U, Sherrill D, Chikani V, Barnhart B, Sotelo M, Gaither JB, Viscusi C, Adelson PD, Denninghoff KR. Evaluation of the impact of implementing the emergency medical services traumatic brain injury guidelines in Arizona: the Excellence in Prehospital Injury Care (EPIC) study methodology. Acad Emerg Med. 2014 Jul;21(7):818-30. doi: 10.1111/acem.12411. Epub 2014 Aug 11.

    PMID: 25112451BACKGROUND

  • Spaite DW, Hu C, Bobrow BJ, Barnhart B, Chikani V, Gaither JB, Denninghoff KR, Bradley GH, Rice AD, Howard JT, Keim SM. Optimal Out-of-Hospital Blood Pressure in Major Traumatic Brain Injury: A Challenge to the Current Understanding of Hypotension. Ann Emerg Med. 2022 Jul;80(1):46-59. doi: 10.1016/j.annemergmed.2022.01.045. Epub 2022 Mar 24.

    PMID: 35339285DERIVED

  • Gaither JB, Spaite DW, Bobrow BJ, Keim SM, Barnhart BJ, Chikani V, Sherrill D, Denninghoff KR, Mullins T, Adelson PD, Rice AD, Viscusi C, Hu C. Effect of Implementing the Out-of-Hospital Traumatic Brain Injury Treatment Guidelines: The Excellence in Prehospital Injury Care for Children Study (EPIC4Kids). Ann Emerg Med. 2021 Feb;77(2):139-153. doi: 10.1016/j.annemergmed.2020.09.435. Epub 2020 Nov 11.

    PMID: 33187749DERIVED

  • Spaite DW, Bobrow BJ, Keim SM, Barnhart B, Chikani V, Gaither JB, Sherrill D, Denninghoff KR, Mullins T, Adelson PD, Rice AD, Viscusi C, Hu C. Association of Statewide Implementation of the Prehospital Traumatic Brain Injury Treatment Guidelines With Patient Survival Following Traumatic Brain Injury: The Excellence in Prehospital Injury Care (EPIC) Study. JAMA Surg. 2019 Jul 1;154(7):e191152. doi: 10.1001/jamasurg.2019.1152. Epub 2019 Jul 17.

    PMID: 31066879DERIVED

  • Spaite DW, Hu C, Bobrow BJ, Chikani V, Barnhart B, Gaither JB, Denninghoff KR, Adelson PD, Keim SM, Viscusi C, Mullins T, Sherrill D. The Effect of Combined Out-of-Hospital Hypotension and Hypoxia on Mortality in Major Traumatic Brain Injury. Ann Emerg Med. 2017 Jan;69(1):62-72. doi: 10.1016/j.annemergmed.2016.08.007. Epub 2016 Sep 28.

    PMID: 27692683DERIVED

MeSH Terms

Conditions

Brain Injuries, TraumaticBrain InjuriesCraniocerebral Trauma

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Daniel W Spaite, MD

    University of Arizona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Emergency Medicine

Study Record Dates

First Submitted

April 15, 2011

First Posted

April 21, 2011

Study Start

September 1, 2011

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

August 28, 2018

Record last verified: 2018-08

Locations

US(1)