A clinical study to assess the diagnostic performance of CEREBO® in detecting intracranial hematoma non-invasively.
- Conditions
- Other specified intracranial injuries,
- Registration Number
- CTRI/2022/04/041634
- Lead Sponsor
- Dr Jaimin Shah
- Brief Summary
Traumatic Brain Injury (TBI) is the leading cause of death and disability across the globe. Time from injury to treatment is the most critical factor that determines the patient’s recovery. Mild TBI with no apparent symptoms are often left undiagnosed, thus delaying the treatment and hence recovery. This observational prospective study determines the efficacy of CEREBO® to detect the intracranial hematoma in comparison with the head CT scan. CEREBO®is a non-invasive, rapid, near-infrared based, point-of-care device. The study also aims to categorise the hematoma based on the bleed volume and depth. Early intracranial hemorrhage detection can help in the patient triaging thus increasing the chances of survival.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 250
Patients with a head injury referred for a CT scan within 72 hours from the onset of first symptoms of closed head injury.
- Patients with scalp bruises or scalp hematoma 2.
- History of neurosurgical procedure (e.g. decompressive craniectomy) with residual bone flap.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity of CEREBO® 1 year Specificity of CEREBO® 1 year Accuracy of CEREBO® 1 year Positive and Negative Predictive Value of CEREBO® 1 year
- Secondary Outcome Measures
Name Time Method Categorisation of intracranial hematoma based on the bleed volume and depth of hematoma using CEREBO® Perform the usability study
Trial Locations
- Locations (1)
Civil Hospital, Ahmedabad
🇮🇳Ahmadabad, GUJARAT, India
Civil Hospital, Ahmedabad🇮🇳Ahmadabad, GUJARAT, IndiaDr Jaimin ShahPrincipal investigator9825576967jaimin_11@yahoo.com