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A Multi-Center Study of Near-Infrared Spectroscopy (NIRS) for Hematoma Detection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
InfraScan, Inc.
ClinicalTrials.gov Identifier:
NCT00576147
First received: December 14, 2007
Last updated: December 19, 2013
Last verified: December 2013
Results First Received: April 11, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Double Blind (Care Provider, Investigator);   Primary Purpose: Diagnostic
Condition: TBI (Traumatic Brain Injury)
Intervention: Device: Infrascanner

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Near-Infrared examinations performed on all patients within 30 minutes before the CT scan of the head and within 12 hours of their head injury

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
CT Scan The standard head CT done to head trauma patients

Participant Flow:   Overall Study
    CT Scan
STARTED   431 
COMPLETED   431 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
CT Scan The standard head CT done to head trauma patients

Baseline Measures
   CT Scan 
Overall Participants Analyzed 
[Units: Participants]
 431 
Age 
[Units: Participants]
 
<=18 years   46 
Between 18 and 65 years   333 
>=65 years   52 
Age 
[Units: Years]
Mean (Standard Deviation)
 36.7  (26) 
Gender 
[Units: Participants]
 
Female   108 
Male   323 
Region of Enrollment 
[Units: Participants]
 
United States   306 
India   125 


  Outcome Measures

1.  Primary:   1) Sensitivity of the Near-Infrared Spectroscopy (NIRS) Measurements for Identifying Intracranial Hematomas Due to Trauma. 2) Specificity of the Near-Infrared Spectroscopy (NIRS) Measurements for Identifying Intracranial Hematomas Due to Trauma.   [ Time Frame: 2 years ]

2.  Secondary:   To Determine the Reproducibility of the Near-Infrared Spectroscopy (NIRS) Measurements With Different Operators and at Different Centers   [ Time Frame: 2 years ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Claudia Robertson
Organization: Baylor College of Medicine
phone: (713) 798-8932
e-mail: claudiar@bcm.edu


Publications of Results:
Other Publications:

Responsible Party: InfraScan, Inc.
ClinicalTrials.gov Identifier: NCT00576147     History of Changes
Other Study ID Numbers: Infrascanner-052306
Study First Received: December 14, 2007
Results First Received: April 11, 2012
Last Updated: December 19, 2013