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CompletedNCT03896789PEGASUSUpdated Jan 29, 2025Results posted

Pediatric Guideline Adherence and Outcomes- Argentina

An interventional study of PEGASUS Program for Care in TBI (Traumatic Brain Injury), sponsored by University of Washington. Completed at 16 sites in 3 countries. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2025-01-29.

Sponsored by University of Washington · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
505
Allocation
Randomized
Ages
Up to 17 Years
Sex
All
01

Study 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 increase TBI guideline adherence. We propose to test the PEGASUS program's ability to improve TBI guideline adherence and outcomes.

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.

02

Conditions studied

  • TBI (Traumatic Brain Injury)

Keywords

  • guideline adherence
  • implementation fidelity
  • pediatric
03

In context

Brain Injuries, Traumatic

1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.

This study's enrollment of 505 is above the median of 52 across 1,088 interventional studies indexed under Brain Injuries, Traumatic.

Browse Brain Injuries, Traumatic studies →

Lead sponsor

University of Washington is the lead sponsor of 1,433 studies on the registry; 225 are open to participants now.

Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.

Browse University of Washington studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • none
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
505 participants (actual)

Study arms

  • No intervention
    Usual Care, then Usual Care (Control)

    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.

  • Experimental
    Usual Care, then PEGASUS Program (Intervention)

    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.

    Other: PEGASUS Program for Care

Interventions

  • OtherPEGASUS Program for Care

    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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: ICU Stay for severe TBI care, first 3 days from admission (or until death or discharge, if before 3 days).

Secondary outcomes

  1. 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.

    Time frame: Started within 24 hours of patient eligibility (at admission or deterioration)

  2. 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.

    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.

  3. Discharge Survival

    Number of survivors at intervention and control sites (descriptive and not powered for this outcome).

    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.

  4. 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)

    Time frame: 3 months post-admission

  5. Mortality, 3-Month

    We will examine participants' mortality at 3 months post discharge

    Time frame: 3 months post admission

Other outcomes

  1. Cumulative First 3-day ICU TBI Guideline Adherence Rate, by Extracranial Injury Status

    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). Here, we stratified by extracranial injury status (isolated TBI vs. TBI and ext

    Time frame: ICU Stay for severe TBI care, first 3 days from admission (or until death or discharge, if before 3 days).

07

Results

Posted Jan 29, 2025

Participant flow

Participants were screened based on ICU admission at 16 South American study hospitals between September 1, 2019 and September 30, 2023. The first participant was enrolled on September 9, 2019 and the last participant was enrolled September 26, 2023.

Baseline
Participant flow — Baseline
MilestoneUsual Care, Then Usual Care (Control)Usual Care, Then PEGASUS Program (Intervention)
Started5561
3-month post-admission follow-up5255
Completed5153
Not completed48
Withdrew: Lost to follow-up12
Withdrew: Death36
Post-Randomization
Participant flow — Post-Randomization
MilestoneUsual Care, Then Usual Care (Control)Usual Care, Then PEGASUS Program (Intervention)
Started208181
3-month post-admission follow-up196168
Completed184157
Not completed2424
Withdrew: Lost to follow-up1211
Withdrew: Death1213

Outcome measures

PrimaryFirst 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).

Time frame:
ICU Stay for severe TBI care, first 3 days from admission (or until death or discharge, if before 3 days).
Reported as:
Mean · mean percentage of guideline adherence
First 3-day Cumulative Intensive Care Unit (ICU) Traumatic Brain Injury (TBI) Guideline Adherence Rate, Overall
mean percentage of guideline adherenceUsual Care, Then Usual Care (Control)Usual Care, Then PEGASUS Program (Intervention)
Baseline81.7 ± 12.981.0 ± 13.2
Post-Randomization83.7 ± 11.584.4 ± 12.8
Statistical analysis
  • Usual Care, Then Usual Care (Control) vs Usual Care, Then PEGASUS Program (Intervention) · Mixed Models Analysis · p = .95 (The primary outcome was analyzed using a multi-level mixed-effects model, which included a random effect for site (to account for potential provider clustering) and fixed effects for covariates.) · Mean difference (final values): 0.1 · 95% CI -3.3 to 3.5Included covariates were age, gender, head maximum AIS, non-head maximum AIS, nurse: patient ratio and baseline TBI guideline adherence scores.
SecondaryClinical 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.

Time frame:
Started within 24 hours of patient eligibility (at admission or deterioration)
Reported as:
Count of participants · Participants
Clinical Pathway Adoption
ParticipantsUsual Care, Then PEGASUS Program (Intervention)
Post-Randomization, Pre-Implementation11
Post-Randomization, Post-Implementation Implemented Clinical Pathway170
Post-Randomization, Post-Implementation Did Not Implement Clinical Pathway0
SecondaryGlasgow 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.

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.
Reported as:
Count of participants · Participants
Glasgow Outcome Scale (GOS) Score at Discharge
ParticipantsUsual Care (Control)PEGASUS Program (Intervention)
Baseline — Death (all-cause)36
Baseline — Vegetative state02
Baseline — Severe disability54
Baseline — Moderate disability319
Baseline — Good recovery4430
Post-Randomization — Death (all-cause)1213
Post-Randomization — Vegetative state159
Post-Randomization — Severe disability1817
Post-Randomization — Moderate disability2442
Post-Randomization — Good recovery139100
SecondaryDischarge Survival

Number of survivors at intervention and control sites (descriptive and not powered for this outcome).

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.
Reported as:
Count of participants · Participants
Discharge Survival
ParticipantsUsual Care, Then Usual Care (Control)Usual Care, Then PEGASUS Program (Intervention)
Baseline — Died in-hospital36
Baseline — Survived5255
Post-Randomization — Died in-hospital1213
Post-Randomization — Survived196168
SecondaryGlasgow 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)

Time frame:
3 months post-admission
Reported as:
Count of participants · Participants
Glasgow Outcome Scale-Extended, Pediatric Version (GOSE-Peds)
ParticipantsUsual Care (Control)PEGASUS Program (Intervention)
Baseline — Death00
Baseline — Vegetative state02
Baseline — Severe disability-lower58
Baseline — Severe disability-upper710
Baseline — Moderate disability-lower01
Baseline — Moderate disability-upper41
Baseline — Good recovery-lower34
Baseline — Good recovery-upper3227
Post-Randomization — Death00
Post-Randomization — Vegetative state69
Post-Randomization — Severe disability-lower2725
Post-Randomization — Severe disability-upper1117
Post-Randomization — Moderate disability-lower44
Post-Randomization — Moderate disability-upper98
Post-Randomization — Good recovery-lower2626
Post-Randomization — Good recovery-upper10168
SecondaryMortality, 3-Month

We will examine participants' mortality at 3 months post discharge

Time frame:
3 months post admission
Reported as:
Count of participants · Participants
Mortality, 3-Month
ParticipantsUsual Care (Control)PEGASUS Program (Intervention)
Baseline — Died00
Baseline — Survived5153
Post-Randomized — Died00
Post-Randomized — Survived184157
Other pre-specifiedCumulative First 3-day ICU TBI Guideline Adherence Rate, by Extracranial Injury Status

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). Here, we stratified by extracranial injury status (isolated TBI vs. TBI and ext

Time frame:
ICU Stay for severe TBI care, first 3 days from admission (or until death or discharge, if before 3 days).
Reported as:
Mean · mean percentage of guideline adherence
Cumulative First 3-day ICU TBI Guideline Adherence Rate, by Extracranial Injury Status
mean percentage of guideline adherenceUsual Care, Then Usual Care (Control)Usual Care, Then PEGASUS Program (Intervention)
Baseline, Isolated TBI (non-head AIS=0)80.2 ± 12.184.3 ± 12.2
Baseline, Extracranial injury (non-head AIS>0)83.0 ± 13.479.6 ± 13.4
Post-Randomization, Isolated TBI (non-head AIS=0)81 ± 13.986.2 ± 12.4
Post-Randomization, Extracranial injury (non-head AIS>0)84.8 ± 10.284.0 ± 12.9
Statistical analysis
  • Usual Care, Then Usual Care (Control) vs Usual Care, Then PEGASUS Program (Intervention) · Mixed Models Analysis · p = .01 (The outcome was analyzed using a multi-level mixed-effects model, which included a random effect for site (to account for potential provider clustering) and fixed effects for covariates.) · Mean difference (final values): 7.9 · 95% CI 1.9 to 13.8Included covariates were age, gender, head maximum AIS, non-head maximum AIS, nurse: patient ratio and baseline TBI guideline adherence scores.

Adverse events

Collected over 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.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Usual Care at Baseline (Site That Was Later Assigned to the Control)3/55 (5.5%)6/55 (10.9%)21/55 (38.2%)
Usual Care at Post-Randomization Control Site12/208 (5.8%)34/208 (16.3%)72/208 (34.6%)
Usual Care at Baseline (Site That Was Later Assigned to the Intervention)6/61 (9.8%)7/61 (11.5%)16/61 (26.2%)
PEGASUS Program at Post-Randomization Intervention Site13/181 (7.2%)17/181 (9.4%)78/181 (43.1%)
Most frequent serious events
Showing 10 of 11
Most frequent serious events
EventUsual Care at Baseline (Site That Was Later Assigned to the Control)Usual Care at Post-Randomization Control SiteUsual Care at Baseline (Site That Was Later Assigned to the Intervention)PEGASUS Program at Post-Randomization Intervention Site
ShockGeneral disorders4/5517/2083/618/181
Other: NeurologicalNervous system disorders0/5512/2081/614/181
PneumoniaInfections and infestations1/559/2081/615/181
Intraparenchymal hemorrhageNervous system disorders2/553/2081/612/181
Other: RespiratoryRespiratory, thoracic and mediastinal disorders2/553/2082/610/181
Other: Electrolyte/MetabolicMetabolism and nutrition disorders0/554/2080/611/181
ArrhythmiaCardiac disorders0/552/2080/611/181
Other: InfectiousInfections and infestations0/552/2080/611/181
Other: CardiacCardiac disorders0/551/2080/610/181
PeritonitisInfections and infestations0/550/2080/610/181
Most frequent other events
Showing 10 of 15
Most frequent other events
EventUsual Care at Baseline (Site That Was Later Assigned to the Control)Usual Care at Post-Randomization Control SiteUsual Care at Baseline (Site That Was Later Assigned to the Intervention)PEGASUS Program at Post-Randomization Intervention Site
PneumoniaInfections and infestations6/5549/20810/6140/181
Other: NeurologicalNervous system disorders5/5520/2082/6121/181
Other: InfectiousInfections and infestations4/554/2084/6119/181
Other: RespiratoryRespiratory, thoracic and mediastinal disorders5/554/2080/613/181
ShockGeneral disorders2/553/2081/612/181
Intraparenchymal hemorrhageNervous system disorders2/552/2081/611/181
Other: CardiacCardiac disorders1/550/2080/610/181
Other: Electrolyte/MetabolicMetabolism and nutrition disorders1/552/2081/612/181
Other: HematologyBlood and lymphatic system disorders0/552/2081/613/181
PeritonitisInfections and infestations0/550/2081/611/181

Baseline characteristics

16 sites contributed participants during baseline period. After randomization, 8 of those sites were assigned Control and 8 were assigned Intervention. Participants were allocated to the study arms based on their admission to either the control study hospitals or intervention study hospitals.

Age, Continuous
Age, Continuous(years)Usual Care, Then Usual Care (Control)Usual Care, Then PEGASUS Program (Intervention)Total
Baseline6.2 ± 4.77.7 ± 5.77.0 ± 5.3
Post-Randomization6.9 ± 4.57.8 ± 4.87.3 ± 4.7
Sex: Female, Male
Sex: Female, Male(Participants)Usual Care, Then Usual Care (Control)Usual Care, Then PEGASUS Program (Intervention)Total
Baseline — Female192342
Baseline — Male363874
Post-Randomization — Female7758135
Post-Randomization — Male131123254
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Usual Care, Then Usual Care (Control)Usual Care, Then PEGASUS Program (Intervention)Total
Count of participants——0
Total Glasgow Coma Scale (GCS) score <=8
Total Glasgow Coma Scale (GCS) score <=8(Participants)Usual Care, Then Usual Care (Control)Usual Care, Then PEGASUS Program (Intervention)Total
Baseline — At admission <=8354883
Baseline — Deteriorated <=8181331
Baseline — Total GCS >8 (but motor<=5)202
Post-Randomization — At admission <=8146138284
Post-Randomization — Deteriorated <=86243105
Post-Randomization — Total GCS >8 (but motor<=5)000
Any extracranial injury
Any extracranial injury(Participants)Usual Care, Then Usual Care (Control)Usual Care, Then PEGASUS Program (Intervention)Total
Baseline — No201939
Baseline — Yes354277
Post-Randomization — No613192
Post-Randomization — Yes147150297
Injury Severity Scale (ISS)
Injury Severity Scale (ISS)(units on a scale)Usual Care, Then Usual Care (Control)Usual Care, Then PEGASUS Program (Intervention)Total
Baseline26.9 ± 20.828.8 ± 18.727.3 ± 20
Post-Randomization26.3 ± 18.829.6 ± 16.727.8 ± 17.9
08

Study locations

16 sites
  • Hospital el Cruce
    Florencio Varela, Buenos Aires, Argentina
  • Hospital Sor Ludovica
    La Plata, Buenos Aires, Argentina
  • Hospital Interzonal Especializado Materno Infantil
    Mar Del Plata, Buenos Aires, Argentina
  • Hospital Municipal del Nino de San Justo
    San Justo, Buenos Aires, Argentina
  • Hospital de Ninos Eva Peron
    San Fernando Del Valle De Catamarca, Catamarca, Argentina
  • Hospital Materno Infantil Dr. Hector Quintana
    San Salvador De Jujuy, Jujuy, Argentina
  • Hospital Regional Reconquista
    Reconquista, Santa Fe, Argentina
  • Hopital Victor J. Vilela
    Rosario, Santa Fe, Argentina
  • Hospital del Nino Jesus
    San Miguel De Tucumán, Tucuman, Argentina
  • Hospital de La Santisima Trinidad
    Cordoba, Argentina
  • Hospital Humberto Notti
    Mendoza, Argentina
  • Hospital Publico Materno Infantil
    Salta, Argentina
  • Hospital Alassia
    Santa Fe, Argentina
  • Centro Provincial de Salud Infantil Eva Peron
    Santiago Del Estero, Argentina
  • Hospital Carlos Van Buren
    Valparaíso, Chile
  • Hospital de Trauma Manuel Giagni
    Asuncion, Paraguay
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — De-identified data will be shared with Co-Investigators

Supporting information: Informed consent form

Time frame: Monthly as available

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2019 to primary completion in Sep 2023, 48 months.

Results were first posted in Jan 2025, 1 year 4 months after primary completion.

Of 442 non-industry interventional studies with no phase under Brain Injuries, Traumatic, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 64. This study's 48 months is above that.

Counting every sponsor, half of 464 studies reached it within 40 months; a quarter within 22 and three quarters within 64.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 7, 2019
First posted
Apr 1, 2019
StartActual
Sep 9, 2019
Primary completionActual
Sep 26, 2023
CompletionActual
Dec 31, 2023
Results first posted
Jan 29, 2025
Last update
Jan 29, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03896789
Lead sponsor
University of Washington
Collaborators
Children's National Research Institute, Centro de Informática e Investigación Clínica (CIIC), Washington State University, National Institute of Neurological Disorders and Stroke (NINDS)
Responsible party
Monica Vavilala (Professor, School of Medicine: Anesthesiology and Pain Medicine, University of Washington) — Principal investigator
First posted
Apr 1, 2019
Start date
Sep 9, 2019
Primary completion
Sep 26, 2023
Completion
Dec 31, 2023
Results posted
Jan 29, 2025
Last update
Jan 29, 2025

Study contacts

Monica Vavilala, MD
principal investigator · University of Washington

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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