TBI (Traumatic Brain Injury)PEGASUSNCT03896789

Pediatric Guideline Adherence and Outcomes- Argentina

A study testing PEGASUS Program for Care in people with TBI (Traumatic Brain Injury), run by University of Washington at 16 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Pediatric traumatic brain injury (TBI) is the leading killer of children worldwide but effective treatments for TBI are limited. Although evidenced-based pediatric TBI guidelines exist, adherence to these guidelines is low,leading us to develop a new Pediatric Guideline Adherence and Outcomes (PEGASUS) program to… Read more about this study

Who is it for?: Ages Up to 17 years
Conditions the study is for: TBI (Traumatic Brain Injury)
What is being tested?: PEGASUS Program for Care
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 505 participants
Where: 16 sitesin 3 countries
Study dates: 9 Sep 2019to 31 Dec 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Up to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Mechanism or head CT consistent with TBI
<18 years old
Glasgow Coma Scale (GCS) score ≤8 at any point during hospital admission, motor GCS≤5 if intubated

Who cannot join

none

Trial locations and contacts

16 sites in 3 countries.

Country

City, postcode or hospital

16 sites in 3 countries

Argentina14 sites

Hospital de Ninos Eva Peron
Catamarca, Catamarca Province
Hospital de La Santisima Trinidad
Córdoba
Hospital Sor Ludovica
La Plata, Buenos Aires
Hospital Interzonal Especializado Materno Infantil
Mar del Plata, Buenos Aires
Hospital Humberto Notti
Mendoza
Hospital Regional Reconquista
Reconquista, Santa Fe Province
Hopital Victor J. Vilela
Rosario, Santa Fe Province
Hospital Publico Materno Infantil
Salta
Hospital el Cruce
San Juan Bautista, Buenos Aires
Hospital Municipal del Nino de San Justo
San Justo, Buenos Aires
Hospital del Nino Jesus
San Miguel de Tucumán, Tucumán Province
Hospital Materno Infantil Dr. Hector Quintana
San Salvador de Jujuy, Jujuy Province
Hospital Alassia
Santa Fe
Centro Provincial de Salud Infantil Eva Peron
Santiago del Estero

Other trials in Argentina

Chile1 site

Hospital Carlos Van Buren
Valparaíso

Other trials in Chile

Paraguay1 site

Hospital de Trauma Manuel Giagni
Asunción

Other trials in Paraguay

About this study

Official title: Implementation Fidelity and Benefits of the Critical Care Pediatric Guideline Adherence and Outcomes Program in Traumatic Brain Injury

Read the detailed description

Specific Aim 1: Determine the relationship between PEGASUS program implementation and TBI guideline adherence (Aim 1a), and assess system, provider, patient, implementation and guideline factors associated with TBI guideline adherence (Aim 1b). Hypothesis: Centers that receive the PEGASUS program have higher TBI guideline adherence (main outcome), as well as better discharge survival and 3-month Glasgow Outcome Scale-Extended (GOSE) score (secondary outcomes) than centers who receive usual care.

Specific Aim 2: Create a value stream map (VSM) to identify value-added processes of care associated with TBI guideline adherence. Hypothesis: ICU activity flows of TBI care during the first 72 hours will reveal value-added as well as non-value-added processes in severe TBI care. PEGASUS program implementation will result in more value-added TBI care processes and better TBI guideline adherence.

Specific Aim 3: Use computer simulation to develop and disseminate a real-world best practices blueprint for TBI guideline adherence. Hypothesis: This model will identify the impact of the PEGASUS program on key performance indicators (KPIs), outcomes (Aim 1), and process activities (Aim 2). Iterative computer simulations will then demonstrate the relationship among PEGASUS program components and how relative changes in these components impact the magnitude, direction and choice of operations downstream in TBI care and patient outcomes to inform development of a blueprint for wide dissemination of best-practice guidelines.

Conditions: TBI (Traumatic Brain Injury)
Being tested: PEGASUS Program for Care
Keywords: guideline adherence, implementation fidelity, pediatric
Medical subject headings: Brain Injuries, Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PEGASUS Program for CareOther
This is in essence a checklist of pediatric guidelines to follow for participants who meet inclusion criteria. Site staff will receive training in how to implement this pathway into their usual care.

Study groups in NCT03896789
Study group	Role	What they receive
Usual Care, then Usual Care (Control)	No intervention	All sites will collect usual care data during the baseline and post-randomization study periods. This arm (half of the sites) will maintain usual care. They will receive the opportunity for the PEGASUS program training (intervention) at the end of study.
Usual Care, then PEGASUS Program (Intervention)	Experimental	All sites will collect usual care data during the baseline study period. With intention-to-treat, after randomization, this arm (half of the sites) will be considered experimental and receive intervention training and then deliver the PEGASUS program (intervention) along with other Usual Care. Receives: Other: PEGASUS Program for Care

What is being measured

The primary outcome is the main question the study is designed to answer.

First 3-day Cumulative Intensive Care Unit (ICU) Traumatic Brain Injury (TBI) Guideline Adherence Rate, Overall
Adherence to nine of the 15 Brain Trauma Foundation TBI guideline indicators were determined for indicators that were logistically relevant in the South American clinical care context.
To determine the first 3-day cumulative ICU TBI guideline adherence rate, adherence to each indicator was first determined for each participant and coded as yes/no/not applicable for each day. For continuous indicators, the daily guideline adherence rate to each indicator was averaged over the first three days. For non-continuous indicators, the daily guideline adherence rate to each indicator was defined as 100% if adherence was achieved within any of the first three days. The 3-day cumulative ICU TBI guideline adherence rate, overall was determined by averaging adherence rates across all nine guideline indicators. Guideline adherence was clustered by site and grouped by site allocation (control or intervention).
Measured: ICU Stay for severe TBI care, first 3 days from admission (or until death or discharge, if before 3 days).

Secondary outcomes (5)

Clinical Pathway Adoption
This outcome will be measured as yes/no for each participant at intervention sites to assess intervention delivery. In essence, the intervention started (use of PEGASUS program clinical pathway) within 24 hours of their eligibility and enrollment.
Due to our intention-to-treat analysis plan, participants who enrolled after randomization but before intervention implementation at intervention sites are included in the analysis. Although they could not have implemented the intervention, sites were aware of their allocation status and were preparing and training during this interval.
Measured: Started within 24 hours of patient eligibility (at admission or deterioration)
Glasgow Outcome Scale (GOS) Score at Discharge
Participants' GOS score at hospital discharge from medical record:
Death-1 (worse) Vegetative State-2 Severe Disability-3 Moderate Disability-4 Good Recovery-5 (better)
The timing varies for each participant since the duration of hospitalization depended on the clinical care factors of each individual and could not be controlled by the study.
Measured: Assessed at Discharge. This varies for each participant since the duration of hospitalization depended on the clinical care factors of each individual and could not be controlled by the study.
Discharge Survival
Number of survivors at intervention and control sites (descriptive and not powered for this outcome).
Measured: Assessed at Discharge. This varies for each participant since the duration of hospitalization depended on the clinical care factors of each individual and could not be controlled by the study.
Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds)
We will examine participants' recovery using GOSE-Peds scores. These were assessed by site study staff either in-person, by telephone, or from medical record approximately 3 months after the admission date.
Death-8 (worse) Vegetative State-7 Severe Disability lower-6 Severe Disability upper-5 Moderate Disability lower-4 Moderate Disability upper-3 Good Recovery lower-2 Good Recovery upper-1 (better)
Measured: 3 months post-admission
Mortality, 3-Month
We will examine participants' mortality at 3 months post discharge
Measured: 3 months post admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Sep 201931 Dec 2023

First posted1 Apr 2019
Study start9 Sep 2019
Primary completion26 Sep 2023
Study completion31 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for TBI (Traumatic Brain Injury)Studies of the same condition, open and under way.
More trials run by University of WashingtonThe sponsor's other registered studies.
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: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Model description: Parallel cluster randomized cluster trial (RCT) following a baseline data collection period when all sites are in the 'control/usual care state'.
Masking: None (open label)
Enrolment: 505 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03896789
Sponsor's protocol ID: STUDY00005629
Other IDs: 1R01NS106560-01A1
Acronym: PEGASUS
Status last verified: Jan 2025
First submitted: 7 Jan 2019
Last updated: 29 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified data will be shared with Co-Investigators

Publications

Vavilala MS, Lujan S, Velonjara J, Bell MJ, Guadagnoli N, Wang J, Mock C, Weiner BJ, Petroni G; Pediatric Guideline Adherence and Outcomes (PEGASUS) Argentina study group. Results of the Pediatric Guideline Adherence and Outcomes (PEGASUS) Program Versus Usual Care Pragmatic Randomized Controlled Trial in Severe Traumatic Brain Injury. Crit Care Med. 2026 Jun 1;54(6):1442-1453. doi: 10.1097/CCM.0000000000007118. Epub 2026 Mar 27.
PubMed 41891786
Velonjara J, Mills B, Lujan S, Petroni G, Bell MJ, Guadagnoli N, Mock C, Hughes JP, Vavilala MS, Rowhani-Rahbar A; PEGASUS Argentina Study Group. The Pediatric Guideline Adherence and Outcomes (PEGASUS Argentina) program in severe traumatic brain injury: study protocol adaptations during the COVID-19 pandemic for a multisite implementation-effectiveness cluster randomized controlled trial. Trials. 2022 Dec 5;23(1):980. doi: 10.1186/s13063-022-06938-x.
PubMed 36471399

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury

All TBI (Traumatic Brain Injury) trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Implementation Fidelity and Benefits of the Critical Care Pediatric Guideline Adherence and Outcomes Program in Traumatic Brain Injury
ClinicalTrials.gov ID: NCT03896789
Acronym / sponsor ID: PEGASUS / STUDY00005629
Conditions: TBI (Traumatic Brain Injury)
Keywords: guideline adherence, implementation fidelity, pediatric
Study type: Interventional
Recruitment status: Completed
Enrolment: 505 participants (actual)
Lead sponsor: University of WashingtonUniversity, hospital or other
Collaborators: Children's National Research Institute, Centro de Informática e Investigación Clínica (CIIC), Washington State University, National Institute of Neurological Disorders and Stroke (NINDS)
Study start: 9 Sep 2019 (actual)
Primary completion: 26 Sep 2023 (actual)
Study completion: 31 Dec 2023 (actual)
First posted: 1 Apr 2019 (actual)
Results: Posted 29 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Parallel cluster randomized cluster trial (RCT) following a baseline data collection period when all sites are in the 'control/usual care state'.

Arm	Type	Receives
Usual Care, then Usual Care (Control)	No intervention	–All sites will collect usual care data during the baseline and post-randomization study periods. This arm (half of the sites) will maintain usual care. They will receive the opportunity for the PEGASUS program training (intervention) at the end of study.
Usual Care, then PEGASUS Program (Intervention)	Experimental	Other: PEGASUS Program for CareAll sites will collect usual care data during the baseline study period. With intention-to-treat, after randomization, this arm (half of the sites) will be considered experimental and receive intervention training and then deliver the PEGASUS program (intervention) along with other Usual Care.

Who may qualify

Ages: Up to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Mechanism or head CT consistent with TBI
<18 years old
Glasgow Coma Scale (GCS) score ≤8 at any point during hospital admission, motor GCS≤5 if intubated

Key exclusion criteria (1 listed)

none

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PEGASUS Program for CareThis is in essence a checklist of pediatric guidelines to follow for participants who meet inclusion criteria. Site staff will receive training in how to implement this pathway into their usual care.	Other	Usual Care, then PEGASUS Program (Intervention)

Primary outcome

First 3-day Cumulative Intensive Care Unit (ICU) Traumatic Brain Injury (TBI) Guideline Adherence Rate, Overall
Time frame: ICU Stay for severe TBI care, first 3 days from admission (or until death or discharge, if before 3 days).
Adherence to nine of the 15 Brain Trauma Foundation TBI guideline indicators were determined for indicators that were logistically relevant in the South American clinical care context. To determine the first 3-day cumulative ICU TBI guideline adherence rate, adherence to each indicator was first determined for each participant and coded as yes/no/not applicable for each day. For continuous indicators, the daily guideline adherence rate to each indicator was averaged over the first three days. For non-continuous indicators, the daily guideline adherence rate to each indicator was defined as 100% if adherence was achieved within any of the first three days. The 3-day cumulative ICU TBI guideline adherence rate, overall was determined by averaging adherence rates across all nine guideline indicators. Guideline adherence was clustered by site and grouped by site allocation (control or intervention).

5 secondary outcomes

Clinical Pathway Adoption
Time frame: Started within 24 hours of patient eligibility (at admission or deterioration)
Glasgow Outcome Scale (GOS) Score at Discharge
Time frame: Assessed at Discharge. This varies for each participant since the duration of hospitalization depended on the clinical care factors of each individual and could not be controlled by the study.
Discharge Survival
Time frame: Assessed at Discharge. This varies for each participant since the duration of hospitalization depended on the clinical care factors of each individual and could not be controlled by the study.
Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds)
Time frame: 3 months post-admission
Mortality, 3-Month
Time frame: 3 months post admission

Results and safety

Results posted to the registry on 29 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Usual Care, Then Usual Care (Control)	55	51
Usual Care, Then PEGASUS Program (Intervention)	61	53

Primary outcome: First 3-day Cumulative Intensive Care Unit (ICU) Traumatic Brain Injury (TBI) Guideline Adherence Rate, Overall

Time frame: ICU Stay for severe TBI care, first 3 days from admission (or until death or discharge, if before 3 days).. Mean (Standard Deviation). Unit: mean percentage of guideline adherence

Measure	Usual Care, Then Usual Care (Control) n = 263	Usual Care, Then PEGASUS Program (Intervention) n = 242
Baseline	81.7 (12.9)	81.0 (13.2)
Post-Randomization	83.7 (11.5)	84.4 (12.8)

Usual Care, Then Usual Care (Control) vs Usual Care, Then PEGASUS Program (Intervention): Mean Difference (Final Values): 0.1 (95% CI -3.3 to 3.5), p = .95, Mixed Models Analysis

Population analysed: We compared control and intervention arms post-randomization (07/13/20) in statistical analysis. Baseline period data contributed to other adjusted analyses.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events data (in-hospital complications and in-hospital mortality) were collected for all participants, all study periods (baseline and post-randomization), and all arms. Individual participants' data were collected for the timeframe of their study hospital admission date through their study hospital discharge which varied depending on the individual participant's clinical care needs and was not controlled by the study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care at Baseline (Site That Was Later Assigned to the Control)	6 of 55 (10.9%)	21 of 55 (38.2%)	3 of 55
Usual Care at Post-Randomization Control Site	34 of 208 (16.3%)	72 of 208 (34.6%)	12 of 208
Usual Care at Baseline (Site That Was Later Assigned to the Intervention)	7 of 61 (11.5%)	16 of 61 (26.2%)	6 of 61
PEGASUS Program at Post-Randomization Intervention Site	17 of 181 (9.4%)	78 of 181 (43.1%)	13 of 181

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41891786Vavilala MS, Lujan S, Velonjara J, Bell MJ, Guadagnoli N, Wang J, Mock C, Weiner BJ, Petroni G; Pediatric Guideline Adherence and Outcomes (PEGASUS) Argentina study group. Results of the Pediatric Guideline Adherence and Outcomes (PEGASUS) Program Versus Usual Care Pragmatic Randomized Controlled Trial in Severe Traumatic Brain Injury. Crit Care Med. 2026 Jun 1;54(6):1442-1453. doi: 10.1097/CCM.0000000000007118. Epub 2026 Mar 27.
Derived from this study: PubMed 36471399Velonjara J, Mills B, Lujan S, Petroni G, Bell MJ, Guadagnoli N, Mock C, Hughes JP, Vavilala MS, Rowhani-Rahbar A; PEGASUS Argentina Study Group. The Pediatric Guideline Adherence and Outcomes (PEGASUS Argentina) program in severe traumatic brain injury: study protocol adaptations during the COVID-19 pandemic for a multisite implementation-effectiveness cluster randomized controlled trial. Trials. 2022 Dec 5;23(1):980. doi: 10.1186/s13063-022-06938-x.
Individual participant dataSharing planned: Yes. De-identified data will be shared with Co-Investigators

Related trials for TBI (Traumatic Brain Injury)

Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
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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.

Monica Vavilala, MD principal investigator

University of Washington

16 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PEGASUS Program for Care in people with TBI (Traumatic Brain Injury), run by University of Washington at 16 sites in 3 countries.

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 3 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 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Argentina, Chile, Paraguay. 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?

Yes. Results are posted in the registry (first posted 29 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

First 3-day Cumulative Intensive Care Unit (ICU) Traumatic Brain Injury (TBI) Guideline Adherence Rate, Overall (time frame: ICU Stay for severe TBI care, first 3 days from admission (or until death or discharge, if before 3 days).). 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 NCT03896789, which also lists 2 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 29 Jan 2025.