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Computed Tomography Perfusion in Patients With Severe Head Injury

Primary Purpose

Brain Injuries

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
ct perfusion
Sponsored by
Nova Scotia Health Authority
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Injuries focused on measuring computed tomography, perfusion imaging, brain death, traumatic brain injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • at least 18 years old
  • severe head injury with Glasgow Coma Scale score ≤ 8 after initial resuscitation
  • on mechanical respiratory support at the time of imaging

Exclusion Criteria:

  • known to be pregnant
  • any known contraindication to CT contrast agent, such as an allergy or anaphylactic reaction
  • known end-stage renal disease (on chronic dialysis or to be expected)

Sites / Locations

  • Queen Elizabeth II Health Sciences Centre-Halifax Infirmary

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

ct perfusion

Arm Description

All participants will undergo the imaging protocol with CTP of head at the time of initial diagnostic imaging upon hospital arrival.

Outcomes

Primary Outcome Measures

death
the death of the participant due to any cause at discharge

Secondary Outcome Measures

recruitment rate
Number of potential participants approached who agreed to participate

Full Information

First Posted
April 26, 2016
Last Updated
April 28, 2016
Sponsor
Nova Scotia Health Authority
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1. Study Identification

Unique Protocol Identification Number
NCT02756585
Brief Title
Computed Tomography Perfusion in Patients With Severe Head Injury
Official Title
Computed Tomography Perfusion in Patients With Severe Head Injury
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Scotia Health Authority

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
To demonstrate that CTP is useful for assessing patients with severe TBI, the investigators will conduct a large study at multiple hospitals across Canada. Before conducting the large study, the investigators need to make sure that it is feasible to add CTP of the head to the routine imaging that patients with severe TBI undergo at the time of their arrival at the hospital. The current study is a pilot study to test the feasibility of adding CTP imaging of the head to the routine imaging protocol for patients with severe TBI at the time of their hospital admission. The proposed feasibility study will help determine how many participants the investigators need for the larger study to attain a significant result and whether the investigators need to modify the investigators study methods. Participants will undergo the imaging protocol with CTP of head at the time of initial diagnostic imaging upon hospital arrival. Non-contrast CT (NCCT) of the head will be performed as part of current imaging protocol for severe TBI patients. At the time of the NCCT, participants will undergo whole-brain CTP protocol, ensuring coverage of the entire brainstem. A total of 40 mL of nonionic iodinated contrast media will be injected. Images will be acquired according to the investigators previously published imaging protocol. Cerebral blood flow (CBF) and cerebral blood volume (CBV) images from the CTP will be qualitatively assessed for the presence or absence of a matched decrease of CBF and CBV in the brainstem. CTP will be assessed independently by two radiologists blinded from each other. If disagreements arise, they will be resolved by discussion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries
Keywords
computed tomography, perfusion imaging, brain death, traumatic brain injury

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ct perfusion
Arm Type
Other
Arm Description
All participants will undergo the imaging protocol with CTP of head at the time of initial diagnostic imaging upon hospital arrival.
Intervention Type
Radiation
Intervention Name(s)
ct perfusion
Intervention Description
computed tomography perfusion of the head
Primary Outcome Measure Information:
Title
death
Description
the death of the participant due to any cause at discharge
Time Frame
until hospital discharge, up to 1 year
Secondary Outcome Measure Information:
Title
recruitment rate
Description
Number of potential participants approached who agreed to participate
Time Frame
through study completion, up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: at least 18 years old severe head injury with Glasgow Coma Scale score ≤ 8 after initial resuscitation on mechanical respiratory support at the time of imaging Exclusion Criteria: known to be pregnant any known contraindication to CT contrast agent, such as an allergy or anaphylactic reaction known end-stage renal disease (on chronic dialysis or to be expected)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jai Shankar, MD
Phone
902-473-5448
Email
shivajai1@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jai Shankar, MD
Organizational Affiliation
Nova Scotia Health Authority
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Elizabeth II Health Sciences Centre-Halifax Infirmary
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23275594
Citation
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.
Results Reference
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Computed Tomography Perfusion in Patients With Severe Head Injury

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