Study of clinical usefulness of blood biomarkers for mild head injury

Not Applicable

Recruiting

• Conditions: mild traumatic brain injury

• Registration Number: JPRN-UMIN000049943
• Lead Sponsor: International University of Health and Welfare

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-04-01
• Last Update Posted: 1 April 2024
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 615

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients participating in therapeutic clinical studies with interventions that impact the outcome of this study (observational studies are acceptable) 2) Patients with unknown time of trauma 3) Patients with a primary diagnosis of ischemic or hemorrhagic stroke at an enrollment center 4) Patients unable to perform venipuncture (skin integrity compromised at venipuncture site, vascular calcification (i.e., IV drug users, advanced atherosclerosis), both upper extremity absent . 5) Patients who are not fit for a CT scanner (eg morbidly obese or claustrophobic) 6) Patients who received a blood transfusion after head trauma prior to blood collection for this study 7) Female patients who are pregnant or breastfeeding 8) Patients without written informed consent 9) If the collected blood specimen is markedly hemolyzed or turbid 10) When the sample volume is significantly insufficient (1 mL or less)

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) In patients with a GCS score of 13 to 15, no neurodegenerative disease or neuropathy, and no history of brain disease within the past 30 days, the lower limit of the two-sided 95% confidence interval of the blood biomarker sensitivity is 85% or higher to determine non-inferiority, when compared with CT examination. 2) In patients with a GCS score of 13 to 15, no neurodegenerative disease or neuropathy, and no history of brain disease within the past 30 days, the negative predictive value for blood biomarkers is more than 97% when the CT positive rate is set to 6%, the same as in the United States.