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Beyond One Option for the Treatment of Severe Traumatic Brain Injury

NCT06787040 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 96

Last updated 2025-05-08

No results posted yet for this study

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

Interventions

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/

Sponsors & Collaborators

  • NIHR Global Health Research Group on Neurotrauma

    collaborator UNKNOWN

  • Gates Cambridge

    collaborator OTHER

  • Meditech Foundation

    lead OTHER

Principal Investigators

  • Andres M Rubiano, MD · Meditech Foundation

  • Peter J Hutchinson, MD, PhD · University of Cambridge

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-12-30
Completion
2025-05-05

Countries

  • Colombia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06787040 on ClinicalTrials.gov