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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02222597
Other study ID # 201209046DPB
Secondary ID
Status Recruiting
Phase N/A
First received August 20, 2014
Last updated August 24, 2014
Start date April 2014

Study information

Verified date August 2014
Source National Taiwan University Hospital
Contact Meng-Che Wu, MD
Phone +886-972653208
Email mengcher111@gmail.com
Is FDA regulated No
Health authority Taiwan: Ministry of Health and Welfare
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate Near-Infrared Spectroscopy for intracranial hematoma detection of head trauma patients


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

The patients within 12 hours after head injury, visiting the Emergency Department of the National Taiwan University Hospital, and receiving computed tomography of head were enrolled.

Exclusion Criteria:

1. The patients over 12 hours after head injury, visiting the Emergency Department of the NTUH, and receiving computed tomography of head were excluded.

2. Patients with massive scalp laceration or hematoma were excluded. -

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Device:
infrascanner


Locations

Country Name City State
Taiwan National Taiwan University Hospital Emergency Department Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary detect the predictive value of the infrascanner for intracranial hemorrhage within 12 hours after head injury No