Beyond One Option for the Treatment of Severe Traumatic Brain Injury

NCT06787040 | Completed DMC

• 1 other identifier: U1111-1272-0282
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 3

Brief Summary

Severe traumatic brain injury (sTBI) is a public health issue with great disparity among low- and middle-income countries where the implementation of evidence-based guidelines is challenging because resources are often unavailable. A consensus process including experts in the prehospital, emergency department, neurosurgery, and intensive care unit took place in Colombia to develop a set of stratified protocols called BOOTStraP, targeting resource-poor environments, but it has not been systematically implemented and tested. To identify the facilitators of, and barriers to, collecting data about patients with sTBI and to implement a stratified protocol across the treatment phases of prehospital, emergency department, neurosurgery, and intensive care unit in low-resource settings. We also aim to identify a possible association between adherence to these protocols and outcomes for these patients. A prospective, observational, before and after, pilot study will be performed in three phases as follows: before implementation, implementation, and after implementation. The BOOTStraP protocols will be implemented in three Colombian centers. We expect to find numerous barriers during the implementation phase. We also expect moderate adherence to the protocols. However, we expect to find an increase in the survival rate to hospital discharge and an improvement in neurological outcomes at discharge. This pilot study will serve as a first step to identify variables that are critical to successful implementation, to be considered for the design of a future large-scale international study to measure the effectiveness of resource-based protocols and to improve outcomes from sTBI.

Conditions

Traumatic Brain Injury

Keywords

TBI; LMIC; Colombia; Resource-Stratified Guidelines

Outcome Measures

Primary Outcomes (2)

• Survival to hospital discharge

  Evaluation of survival and mortality

  From date of injury until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months

• Glasgow Outcome Scale Extended at discharge

  Evaluation of the GOSE from 1 to 8, with 1 as the worst outcome and 8 as the best outcome.

  From date of injury until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months

Study Arms (2)

Before Implementation

Patients managed before the implementation of the stratified protocol for TBI care in the Emergency Room, Surgery, and ICU

After Implementation

Patients managed after the implementation of the stratified protocol for TBI care in the Emergency Room, Surgery, and ICU

Other: Resource-Stratified Protocol

Interventions

Resource-Stratified Protocol OTHER

The interventions are a set of protocols that accounts for varying levels of resources available at any given time for patients with severe traumatic brain injury across prehospital, ED, neurosurgery, and ICU. Protocols are available in the NIH-PMC website at: https://pmc.ncbi.nlm.nih.gov/articles/PMC7055642/

After Implementation

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with TBI in Colombia

You may qualify if:

• Patients ≥ 15 years of age
• Clinical indications of TBI
• GCS ≤ 8 on hospital arrival, or within 48 hours of admission OR GCS ≥9 on hospital arrival, but who are either admitted to the ICU or undergo surgery within 48 hours of admission

You may not qualify if:

• Patient is expired at scene on EMS arrival (patients who expire during transport, either by EMS or private means, are included)

Sponsors & Collaborators

• Meditech Foundation: lead
• NIHR Global Health Research Group on Neurotrauma: collaborator
• Gates Cambridge: collaborator

Study Sites (3)

Clinica Uros Neiva

Neiva, Huila Department, 410001, Colombia

Location

Clinica Putumayo

Puerto Asís, Putumayo Department, 862060, Colombia

Location

Clinica La Sagrada Familia

Armenia, Quindío Department, 630001, Colombia

Location

Related Publications (9)

• Rubiano AM, Vera DS, Montenegro JH, Carney N, Clavijo A, Carreno JN, Gutierrez O, Mejia J, Ciro JD, Barrios ND, Soto AR, Tejada PA, Zerpa MC, Gomez A, Navarrete N, Echeverry O, Umana M, Restrepo CM, Castillo JL, Sanabria OA, Bravo MP, Gomez CM, Godoy DA, Orjuela GD, Arias AA, Echeverri RA, Paranos J. Recommendations of the Colombian Consensus Committee for the Management of Traumatic Brain Injury in Prehospital, Emergency Department, Surgery, and Intensive Care (Beyond One Option for Treatment of Traumatic Brain Injury: A Stratified Protocol [BOOTStraP]). J Neurosci Rural Pract. 2020 Jan;11(1):7-22. doi: 10.1055/s-0040-1701370. Epub 2020 Mar 3.

  PMID: 32140001 BACKGROUND

• Griswold DP, Carney N, Ballarini NM, Fernandez LL, Kolias A, Hutchinson PJ, Rubiano AM. Protocol for a Multicenter, Prospective, Observational Pilot Study on the Implementation of Resource-Stratified Algorithms for the Treatment of Severe Traumatic Brain Injury Across Four Treatment Phases: Prehospital, Emergency Department, Neurosurgery, and Intensive Care Unit. Neurosurgery. 2022 Aug 1;91(2):355-359. doi: 10.1227/neu.0000000000002004. Epub 2022 May 3.

  PMID: 35485862 BACKGROUND

• Jayaraman S, Ozgediz D, Miyamoto J, Caldwell N, Lipnick MS, Mijumbi C, Mabweijano J, Hsia R, Dicker R. Disparities in injury mortality between Uganda and the United States: comparative analysis of a neglected disease. World J Surg. 2011 Mar;35(3):505-11. doi: 10.1007/s00268-010-0871-z.

  PMID: 21181159 BACKGROUND

• Rubiano AM, Carney N, Chesnut R, Puyana JC. Global neurotrauma research challenges and opportunities. Nature. 2015 Nov 19;527(7578):S193-7. doi: 10.1038/nature16035.

  PMID: 26580327 BACKGROUND

• Passmore JW, Nguyen LH, Nguyen NP, Olive JM. The formulation and implementation of a national helmet law: a case study from Viet Nam. Bull World Health Organ. 2010 Oct 1;88(10):783-7. doi: 10.2471/BLT.09.071662. Epub 2010 Aug 30.

  PMID: 20931064 BACKGROUND

• Global Status Report on Road Safety 2018: Summary. World Health Organization; 2018:20.

  BACKGROUND

• Alarcon JD, Gich Saladich I, Vallejo Cuellar L, Rios Gallardo AM, Montalvo Arce C, Bonfill Cosp X. [Mortality in Colombia traffic accidents. Comparative study with other countries]. Rev Esp Salud Publica. 2018 Jul 5;92:e201807040. Spanish.

  PMID: 29967318 BACKGROUND

• Liu BC, Ivers R, Norton R, Boufous S, Blows S, Lo SK. Helmets for preventing injury in motorcycle riders. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD004333. doi: 10.1002/14651858.CD004333.pub3.

  PMID: 18254047 BACKGROUND

• Association WM. Declaration of Helsinki. Accessed November 26, 2021. https://www.wma.net/ policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research- involving-human-subjects/

  BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Andres M Rubiano, MD

  Meditech Foundation

  STUDY DIRECTOR

• Peter J Hutchinson, MD, PhD

  University of Cambridge

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: January 22, 2025
• Study Start: January 1, 2024
• Primary Completion: December 30, 2024
• Study Completion: May 5, 2025
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 01-01-2024 to 01-01-2029
• Access Criteria: Protocol available at: https://pubmed.ncbi.nlm.nih.gov/35485862/

Locations

CO (3)