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NCT04565119 · ClinicalTrials.gov registry record

Biomarkers in the Brain Oxygen Optimization in Severe Traumatic Brain Injury Trial

A clinical trial of TBI (Traumatic Brain Injury), sponsored by University of Pennsylvania.

Recruiting
Registry status
300
Enrollment target
2
Study locations

NCT04565119: Recruiting study of TBI (Traumatic Brain Injury), sponsored by University of Pennsylvania.

NCT04565119 is a study of TBI (Traumatic Brain Injury) that is actively recruiting participants, run by University of Pennsylvania. The registered enrollment target is 300 participants, above the 158-participant average among 20 other TBI (Traumatic Brain Injury) trials with a reported enrollment target (90% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04565119, a study of TBI (Traumatic Brain Injury), is actively recruiting participants, sponsored by University of Pennsylvania.

RECRUITING
Registry status
300 participants
Enrollment target
2
Study locations

Study Summary

BioBOOST is a multicenter, observational study of the effect of derangements in brain physiologic parameters on brain injury biomarker levels in patients with severe traumatic brain injury.

Primary Outcome

This hypothesis will be tested via linear regression model, with peak GFAP level as the response variable and hypoxia exposure as the predictor of interest. Hypoxia exposure will be defined as the depth and duration of PbtO2 \< 20 mmHg during the first 48 hours of injury, quantified using area under the curve (AUC) methodology.

Conditions Studied

TBI (Traumatic Brain Injury)

Interventions

  • OTHER No intervention. This is an observational study.

Study Locations (2)

Michigan

  • University of Michigan - Ann Arbor

Pennsylvania

  • Penn Presbyterian Medical Center - Philadelphia

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2020-12-20
Est. Completion 2027-12-31
University of Pennsylvania

1,423 total trials

What NCT04565119 shows while recruiting

NCT04565119 is an observational study that tracks outcomes without assigning an intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 158-participant average among 20 other TBI (Traumatic Brain Injury) trials with a reported enrollment target (90% higher).

The record links to 1 condition, with TBI (Traumatic Brain Injury) appearing as the primary indexed condition, and to 1 intervention - of which No intervention. This is an observational study. is the first listed.

NCT04565119 reports a single indexed study location in Michigan, Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT04565119 about?

NCT04565119 is a clinical study titled "Biomarkers in the Brain Oxygen Optimization in Severe Traumatic Brain Injury Trial". BioBOOST is a multicenter, observational study of the effect of derangements in brain physiologic parameters on brain injury biomarker levels in patients with severe traumatic brain injury.

What is the current status of trial NCT04565119?

This trial is currently recruiting. The enrollment target is 300 participants. The study started on 2020-12-20. Estimated completion is 2027-12-31.

What conditions does trial NCT04565119 study?

This clinical trial studies the following conditions: TBI (Traumatic Brain Injury).

What interventions are being tested in trial NCT04565119?

The interventions under investigation include: No intervention. This is an observational study. (OTHER).

Who is sponsoring clinical trial NCT04565119?

This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04565119 being conducted?

This trial has 2 study locations across Michigan, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for TBI (Traumatic Brain Injury)

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04565119's enrollment target sits among peer trials

300 5th of 20 higher than 16 of 20 other TBI (Traumatic Brain Injury) trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other TBI (Traumatic Brain Injury) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT04565119

Source: ClinicalTrials.gov NCT04565119, the US trial registry maintained by the National Library of Medicine. NCT04565119 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.