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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02756585
Other study ID # CTP TBI
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 26, 2016
Last updated April 28, 2016
Start date September 2016
Est. completion date December 2018

Study information

Verified date April 2016
Source Nova Scotia Health Authority
Contact Jai Shankar, MD
Phone 902-473-5448
Email shivajai1@gmail.com
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

Traumatic brain injury (TBI) is a leading cause of post-injury hospitalization, disability, and death worldwide. In Nova Scotia, approximately 50% of major trauma reported is head trauma. TBI is predicted to be the most common and expensive neurological condition in Canada through the year 2031.

Families and medical teams must often decide on the appropriate level of care for patients with severe TBI and frequently need to consider withdrawal of life support measures. These decisions have implications for patients with severe TBI, costs to the health care system, and rates of organ donation.

A reliable method for neurological evaluation at the time of the patient's arrival to the hospital is important, because it is possible that many patients with severe TBI already have permanent brain damage. Assessing this brain damage with clinical tests is difficult because of the nature of patients' injuries and the sedative medication they receive at the time of their hospital admission. Current standard imaging technique for these patients is severely limited in the assessment of the extent and severity of the brain damage.

Advanced diagnostic imaging, called Computed Tomography Perfusion (CTP), can help detect permanent brain damage. However, CTP of the head is not currently done for patients with severe TBI when they arrive at the hospital. The investigators want to test whether CTP of the head can detect permanent brain damage among patients with severe TBI.


Description:

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Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Radiation:
ct perfusion
computed tomography perfusion of the head

Locations

Country Name City State
Canada Queen Elizabeth II Health Sciences Centre-Halifax Infirmary Halifax Nova Scotia

Sponsors (1)

Lead Sponsor Collaborator
Nova Scotia Health Authority

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Shankar JJ, Vandorpe R. CT perfusion for confirmation of brain death. AJNR Am J Neuroradiol. 2013 Jun-Jul;34(6):1175-9. doi: 10.3174/ajnr.A3376. Epub 2012 Dec 28. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary death the death of the participant due to any cause at discharge until hospital discharge, up to 1 year No
Secondary recruitment rate Number of potential participants approached who agreed to participate through study completion, up to 2 years No
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