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A clinical study of serological examination in diagnosis and prognosis evaluation of central nervous system diseases

A Clinical study for evaluating the diagnostic and prognostic values of cerebral biomarkers for acute brain injury

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100043218
Enrollment
Unknown
Registered
2021-02-08
Start date
2021-02-16
Completion date
Unknown
Last updated
2021-05-24

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

Conditions

Brain Injury

Interventions

Gold Standard:(1) Detailed medical history inquiry
(2) Detailed medical examination
(3) Conventional CT/MRI imaging examination
(4) Special imaging examination.
GFAP&#32
(Glial&#32
Protein)
PGP9.5&#32
Gene&#32
9.5)
&#32
S100-ß

Sponsors

Xiang'an Hospital of Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: This study will enroll 70 to 80 patients with mild to moderate traumatic brain injury, 70 to 80 patients with early ischemic and hemorrhagic stroke, and 40 to 50 patients without brain injury. The subjects include outpatients, emergency patients and inpatients in Xiang'an Hospital of Xiamen University. The subjects randomly include men and women of all ages. Experimental blood samples will be collected during the routine clinical blood sample collection process.

Exclusion criteria

Exclusion criteria: (1) Patients with severe brain injury; (2) Patients requiring craniotomy; (3) Patients with mild brain injury but no CT imaging examination; (4) Patients with severe coronary heart disease, heart failure or renal failure; (5) Patients with malignant tumor; (6) Patients taking various drugs that may cause increased BBB permeability. (7) Patient with other uncontrolled active infection; (8) The investigator believes that the subject is not suitable for this clinical study due to different reasons.

Design outcomes

Primary

MeasureTime frame
GFAP (Glial Fibrillary Acidic Protein);PGP9.5 (Protein Gene Product 9.5);

Secondary

MeasureTime frame
S100-ß;NSE (Neuron Specific Enolase);

Countries

China

Contacts

Public ContactJun Yang

Xiang'an Hospital of Xiamen University

junyangyang@hotmail.com+86 17091303894

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026