Skip to main content
OpenTrials
Completed

NCT Number: NCT02756585

Computed Tomography Perfusion in Patients With Severe Head Injury

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Brain Injuries Brain Death Brain Diseases Brain Injuries, Traumatic Central Nervous System Diseases Coma Consciousness Disorders Craniocerebral Trauma Death Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Trauma, Nervous System Unconsciousness Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Elizabeth II Health Sciences Centre-Halifax Infirmary

Halifax, Nova Scotia, B3H 3A6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CT Perfusion

Radiation

computed tomography perfusion of the head

Primary outcomes

  1. death

    Time frame: until hospital discharge, up to 1 year

    the death of the participant due to any cause at discharge

Secondary outcomes

  1. recruitment rate

    Time frame: through study completion, up to 2 years

    Number of potential participants approached who agreed to participate

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 29, 2016
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.