Trial reportJournal of neurotrauma2021
Progesterone Treatment Does Not Decrease Serum Levels of Biomarkers of Glial and Neuronal Cell Injury in Moderate and Severe Traumatic Brain Injury Subjects: A Secondary Analysis of the Progesterone for Traumatic Brain Injury, Experimental Clinical Treatment (ProTECT) III Trial.
Trial report in Journal of neurotrauma, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 20 citations in OpenAlex.
- Effects of Progesterone on Preclinical Animal Models of Traumatic Brain Injury: Systematic Review and Meta-analysis.Molecular neurobiology · 2022Pooled it
- Traumatic Brain Injury Severity Measured by Clinical, Radiographical, and Blood Biomarker Measures Is Associated with Non-Neurological Organ Dysfunction: A Secondary Analysis of ProTECT III and Bio-ProTECT.Journal of neurotrauma · 2025Trial
- Progesterone for Traumatic Brain Injury, Experimental Clinical Treatment III Trial Revisited: Objective Classification of Traumatic Brain Injury With Brain Imaging Segmentation and Biomarker Levels.Critical care explorations · 2025Trial
- Clinical utility of jugular venous blood gas biomarkers for assessing cranial brain injury severity and predicting ICU stay duration: A biochemical and predictive modeling approach.Journal of medical biochemistry · 2025Article
- The border-associated macrophage marker MRC1 contributes to an early neuroprotective inflammatory response to traumatic brain injury in mice.Acta neuropathologica communications · 2025Article
- Brain injury biomarkers as targets for drugs development and personalized treatment for traumatic brain injury patients.Frontiers in pharmacology · 2025Review
- The evolving pathophysiology of TBI and the advantages of temporally-guided combination therapies.Neurochemistry international · 2024Review
- Spatial Measurement and Inhibition of Calpain Activity in Traumatic Brain Injury with an Activity-Based Nanotheranostic Platform.ACS nano · 2024Article
- Cognition and Behavior in the Aging Brain Following TBI: Surveying the Preclinical Evidence.Advances in neurobiology · 2024Review
- Early Signs of Elevated Intracranial Pressure on Computed Tomography Correlate With Measured Intracranial Pressure in the Intensive Care Unit and Six-Month Outcome After Moderate to Severe Traumatic Brain Injury.Journal of neurotrauma · 2023Article
- Therapy of traumatic brain injury by modern agents and traditional Chinese medicine.Chinese medicine · 2023Review
- The biological significance and clinical utility of emerging blood biomarkers for traumatic brain injury.Neuroscience and biobehavioral reviews · 2021Review
- Deficiency in Androgen Receptor Aggravates Traumatic Brain Injury-Induced Pathophysiology and Motor Deficits in Mice.Molecules (Basel, Switzerland) · 2021Article
- Association of Age and Sex With Multi-Modal Cerebral Physiology in Adult Moderate/Severe Traumatic Brain Injury: A Narrative Overview and Future Avenues for Personalized Approaches.Frontiers in pharmacology · 2021Review
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Authors and funding
11 authors at 3 institutions in 1 country.
Funding
Abstract
Early treatment of moderate/severe traumatic brain injury (TBI) with progesterone does not improve clinical outcomes. This is in contrast with findings from pre-clinical studies of progesterone in TBI. To understand the reasons for the negative clinical trial, we investigated whether progesterone treatment has the desired biological effect of decreasing brain cell death. We quantified brain cell death using serum levels of biomarkers of glial and neuronal cell death (glial fibrillary acidic protein [GFAP], ubiquitin carboxy-terminal hydrolase-L1 [UCH-L1], S100 calcium-binding protein B [S100B], and Alpha II Spectrin Breakdown Product 150 [SBDP]) in the Biomarkers of Injury and Outcome-Progesterone for Traumatic Brain Injury, Experimental Clinical Treatment (BIO-ProTECT) study. Serum levels of GFAP, UCHL1, S100B, and SBDP were measured at baseline (≤4 h post-injury and before administration of study drug) and at 24 and 48 h post-injury. Serum progesterone levels were measured at 24 and 48 h post-injury. The primary outcome of ProTECT was based on the Glasgow Outcome Scale-Extended assessed at 6 months post-randomization. We found that at baseline, there were no differences in biomarker levels between subjects randomized to progesterone treatment and those randomized to placebo (
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.