Beyond One Option for the Treatment of Severe Traumatic Brain Injury (BOOTStraP)

May 5, 2025 updated by: Andres M. Rubiano, Meditech Foundation

Beyond One Option for the Treatment of Severe Traumatic Brain Injury [BOOTStraP]: A Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

While evidence-based guidelines for the management of sTBI exist, their applicability in low-resource environments is limited, as the resources required to follow guidelines are often unavailable. To address this gap, a consensus process involving clinical experts was conducted in Colombia to develop a series of management protocols to articulate treatment options for TBI specific to different levels of resources and complexity across the prehospital, emergency department (ED), neurosurgery and intensive care (ICU) phases. The set of protocols was called BOOTStraP [Beyond One Option for Treatment of Traumatic Brain Injury: A Stratified Protocol]. The BOOTStraP protocols are divided into four main categories, which are based on 13 recommendations from 20 clinical experts as follows: 1) management in a basic or advanced ambulance (pre-hospital setting), 2) ED care in a low or medium-high complexity institution with or without access to a CT-Scan, 3) neurosurgery department, and 4) intermediate or ICU availability. Each one is subcategorized according to the TBI severity and can be used as a guiding tool by health professionals (e.g. EMS technicians, nurses, physicians, etc.) The user can select from a menu of treatment options depending upon resource availability (medicine, equipment, clinician training, and skill) to follow best practices given the prevailing circumstances.

This is a prospective, observational, before and after study, pilot investigation of the treatment process and outcomes for patients with TBI, who are transported by any means to a medical center for treatment. Data will be collected for each patient through the four phases of prehospital, ED, neurosurgery, and ICU, or until the patient expires. Data will be abstracted from hospital medical records.

From the initiation of the "before" phase, data for each patient will be collected from the initial patient encounter to hospital discharge, for 3 months. The BOOTStraP protocol will be implemented during the month following the end of initial data collection. After implementation ("after" phase), data for each patient will be collected from initial patient encounters to hospital discharge, for 3 months. The treatment protocols to be implemented at each center are available in the open-access published paper at the NIH PMC website: (https://pmc.ncbi.nlm.nih.gov/articles/PMC7055642/).

Each day during active data collection, the Data Collector (DC) for each site arrives at the hospital, accesses the ED records, and identifies patients admitted during the previous 24 hours who may meet inclusion criteria for the study. The DC ascertains information about the potential included patients from ED records and attending caregivers, and identifies those screened and excluded, and those screened and included. Data are transcribed from ED records and caregiver interactions directly into a web-based database. The DC completes data abstraction for included patients. The DC identifies the location and status of newly included patients, and transcribes data about each patient into the database, up to and including the current status. After completing data abstraction for new patients entered within the previous 24 hours, the DC identifies the location and status of patients previously included in the study, and transcribes data about each patient into the database, up to and including the current status. Each day during active data collection, the Study Coordinator (SC) accesses the electronic records and reviews new data entries for errors and missing data. Twice monthly, the SC visits each study site, compares abstracted data with chart records, and meets with the site DC to discuss errors and missing data. The SC and DC make any revisions together, directly into the database. During these visits, the SC records narrative information about reasons for errors and missing data, what is working and not working, and the DCs' perspectives on the barriers to and facilitators of conducting the study. The SC transcribes this narrative information into a qualitative data collection/analysis database. Categorical data will be summarized as frequencies and percentages, while continuous variables will be summarized using mean, median, minimum, maximum, and 25th and 75th percentiles. We will record narrative information from personnel at each site to investigate the barriers to and facilitators of data collection and intervention implementation. These data will be entered into a qualitative data analysis instrument, and Grounded Theory will be utilized to identify common themes. Adherence will be derived by tracking if each recommended BOOTStraP resource was available (yes/no), and if yes, whether it was utilized (yes/no). The analysis of adherence will be presented by treatment phase (prehospital, emergency department, neurosurgery, and intensive care unit). The percentage of adherence to the BOOTStrap protocol will be used as a summary statistic. The study is descriptive in nature and outcome data will be summarized descriptively by phase (before and after). The analysis will explore correlations between adherence levels by phase and individual treatments on outcome data. No hypothesis will be tested. The sample size for the study was determined based on feasibility and no formal calculation of power was performed. Implementation of BOOTStraP should increase survival to hospital discharge, and improve GOS-E at discharge. We expect there will be many barriers to implementation, especially in the pre-hospital stage. We expect adherence to protocols to be modest. This study will provide the basis to plan for a larger multi-center international study.

Study Type

Observational

Enrollment (Actual)

96

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
    • Huila
      • Neiva, Huila, Colombia, 410001
        • Clinica Uros Neiva
    • Putumayo
      • Puerto Asis, Putumayo, Colombia, 862060
        • Clinica Putumayo
    • Quindio
      • Armenia, Quindio, Colombia, 630001
        • Clinica La Sagrada Familia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with TBI in Colombia

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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/

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival to hospital discharge
Time Frame: 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
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
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meditech Foundation

Collaborators

Gates Cambridge
NIHR Global Health Research Group on Neurotrauma

Investigators

  • Study Director: Andres M Rubiano, MD, Meditech Foundation
  • Study Director: Peter J Hutchinson, MD, PhD, University of Cambridge

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

December 30, 2024

Study Completion (Actual)

May 5, 2025

Study Registration Dates

First Submitted

January 26, 2022

First Submitted That Met QC Criteria

January 21, 2025

First Posted (Actual)

January 22, 2025

Study Record Updates

Last Update Posted (Actual)

May 8, 2025

Last Update Submitted That Met QC Criteria

May 5, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1272-0282

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Full data of the study will be available upon request to the main contacts.

IPD Sharing Time Frame

01-01-2024 to 01-01-2029

IPD Sharing Access Criteria

Protocol available at: https://pubmed.ncbi.nlm.nih.gov/35485862/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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