Brain InjuriesNCT02756585
Computed Tomography Perfusion in Patients With Severe Head Injury
A study testing ct perfusion in people with Brain Injuries, run by Nova Scotia Health Authority at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries
- What is being tested?
- ct perfusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCanada
- Study dates
- 30 May 2016to 1 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site
Queen Elizabeth II Health Sciences Centre-Halifax Infirmary
Halifax, Nova Scotia, B3H 3A6
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Brain Injuries
- Being tested
- ct perfusion
- Keywords
- computed tomography, perfusion imaging, brain death, traumatic brain injury
- Medical subject headings
- Brain Injuries, Brain Death, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ct perfusionRadiation
computed tomography perfusion of the head
| Study group | Role | What they receive |
|---|---|---|
| ct perfusion | Other | All participants will undergo the imaging protocol with CTP of head at the time of initial diagnostic imaging upon hospital arrival. Receives: Radiation: ct perfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
death
the death of the participant due to any cause at discharge
Measured: until hospital discharge, up to 1 year
Secondary outcomes (1)
recruitment rate
Number of potential participants approached who agreed to participate
Measured: through study completion, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study start30 May 2016
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jai Shankar, MD, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756585
- Sponsor's protocol ID
- CTP TBI
- Status last verified
- Apr 2016
- First submitted
- 26 Apr 2016
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 23275594
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computed Tomography Perfusion in Patients With Severe Head Injury
- ClinicalTrials.gov ID
- NCT02756585
- Acronym / sponsor ID
- CTP TBI
- Conditions
- Brain Injuries
- Keywords
- computed tomography, perfusion imaging, brain death, traumatic brain injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- 30 May 2016 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ct perfusion | Other | Radiation: ct perfusionAll participants will undergo the imaging protocol with CTP of head at the time of initial diagnostic imaging upon hospital arrival. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ct perfusioncomputed tomography perfusion of the head | Radiation | ct perfusion |
Primary outcome
death
Time frame: until hospital discharge, up to 1 year
the death of the participant due to any cause at discharge
1 secondary outcome
recruitment rate
Time frame: through study completion, up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Background: PubMed 23275594Shankar 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jai Shankar, MD principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ct perfusion in people with Brain Injuries, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
death (time frame: until hospital discharge, up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02756585, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.