Computed Tomography Perfusion in Patients With Severe Head Injury

NCT02756585 | Completed

• 1 other identifier: CTP TBI
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries

Keywords

computed tomography; perfusion imaging; brain death; traumatic brain injury

Outcome Measures

Primary Outcomes (1)

• death

  the death of the participant due to any cause at discharge

  until hospital discharge, up to 1 year

Secondary Outcomes (1)

• recruitment rate

  through study completion, up to 2 years

Study Arms (1)

ct perfusion

OTHER

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

Radiation: ct perfusion

Interventions

ct perfusion RADIATION

computed tomography perfusion of the head

ct perfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Queen Elizabeth II Health Sciences Centre-Halifax Infirmary

Halifax, Nova Scotia, B3H 3A6, Canada

Location

Related 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.

  PMID: 23275594 BACKGROUND

MeSH Terms

Conditions

Brain Injuries; Brain Death; Brain Injuries, Traumatic

Interventions

Cytidine Triphosphate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cytosine Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Jai Shankar, MD

  Nova Scotia Health Authority

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: April 29, 2016
• Study Start: May 30, 2016
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: August 21, 2024

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)