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Clinical Trials/ACTRN12626000814370
ACTRN12626000814370RecruitingNot Applicable

Validation of Glial Fibrillary Acidic Protein (GFAP) and Ubiquitin C-Terminal Hydrolase L1 (UCH-L1) assays as a traumatic brain injury (TBI) prognostication marker

East Metropolitan Health Service0 sites100 target enrollmentStarted: February 5, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
100

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Observational
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 80 Years (—)
Sex
All

Inclusion Criteria

  • •Patients admitted to the ICU who:
  • •Are less than 24 hours since suffering from a traumatic brain injury
  • •Are expected to stay in the ICU for more than 48 hours
  • •Are between 18 and 80 years old
  • •Have CT brain imaging evidence of presence of traumatic brain injury

Exclusion Criteria

  • •Conditions which will cause a rise or alterations in GFAP and UCH-L1 levels independent of the TBI:
  • •Spinal Cord Injury (radiological evidence)
  • •A known central nervous system (CNS) and/or paraneoplastic malignancy.
  • •Acute Kidney Injury (Creatinine levels greater than 1.5x baseline) or End-stage renal failure (receives chronic dialysis)
  • •Pre-existing neurodegenerative disease (Parkinson’s, Alzheimer’s, Lewy body, etc.)
  • •Cardiac arrest / suspected hypoxic-ischaemic encephalopathy.
  • •Pregnancy/lactation/=3 months postpartum
  • •Massive transfusion in the previous 12 hours
  • •Conditions that may interefere with the ability to assess outcomes:
  • •Severe pre-existing physical or mental disability or severe comorbidity that may interfere with the assessment of outcome.

Arms & Interventions

a) Overview of information collected

Intervention: a) Overview of information collected

Investigators

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