Study of clinical usefulness of blood biomarkers for mild head injury

Study of clinical usefulness of blood biomarkers for mild head injury - Study of clinical usefulness of blood biomarkers for mild head injury

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000049943

Enrollment

615

Registered

2023-04-01

Start date

2023-09-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mild traumatic brain injury

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients over the age of 18 2) Patients presenting with head trauma who underwent a routine head CT scan or who were referred with the results of a routine head CT scan. 3) Patients with a GCS score of 13 to 15 at first visit 4) Patients who had a head CT scan and blood drawn within 12 hours of head injury 5) Patients with cerebral dysfunction (one or more of transient loss of consciousness, amnesia, disorientation, neurological deficit).

Exclusion criteria

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)

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactEiichi Suehiro

International University of Health and Welfare, School of Medicine Neurosurgery

esuehiro@iuhw.ac.jp0476355600

Outcome results