Early Diagnosis of Mortality Using Admission CT Perfusion in Severe Traumatic Brain Injury Patients (ACT-TBI Study)

NCT04318665 | Completed

• 1 other identifier: HS23683 (B2020:018)
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

Brief Summary

Background: Severe traumatic brain injury (TBI) is a principal cause of post-injury hospitalization, disability, and death throughout the world. TBI is the leading cause of death and disability among young healthy people under 45 years of age and is predicted to be the most prevalent and costliest neurological condition in Canada through the year 2031. TBI is commonly classified into mild, moderate, and severe categories using the Glasgow Coma Scale (GCS), with "severe TBI" defined as a GCS score ≤ 8. Severe TBI is a clinical emergency, during which the trauma team works swiftly to provide the appropriate care. Outcome assessment after TBI is complex and is influenced by pre-injury and injury factors as well as the patient's response at various stages of recovery. The first 48 hrs in hospital, despite being the most resource-intensive period, unfortunately result in the highest mortality. These patients are on life support at the time of their hospital admission and adequate and reliable clinical examination is impossible. Thus, patients receive treatment despite lack of a clear understanding of their prognoses. Hypothesis: Admission Computed Tomographic Perfusion (CTP) can diagnose brain death reliably in severe TBI patients in early stage upon hospital admission, which is not recognised in the usual clinical practice due to inadequate reliable clinical examination. In a small prospective pilot study of 19 patients with severe TBI, admission CTP could predict early in hospital mortality with 75% sensitivity, 100% specificity, 100% positive predictive value (PPV) and 94% negative predictive value (NPV) and perfect inter-rater reliability (kappa=1). We propose ACT-TBI study to evaluate CTP as a triage tool to diagnose early mortality at the time of admission in patients with severe TBI. Primary Objective: To validate admission CTP features of brain death, relative to the clinical examination outcome, for characterizing early in-hospital mortality. Secondary objectives: To establish the safety and interrater reliability of admission CTP.

Conditions

Traumatic Brain Injury

Keywords

TBI, CTP

Outcome Measures

Primary Outcomes (1)

• The primary outcome is a binary outcome of mortality ('dead') or survival ('not-dead') in the first 48 hours of hospital admission.

  The primary outcome of this study is determining the mortality ('dead') or survival ('not-dead') in the first 48 hours of hospital admission using CTP.

  48 hours

Secondary Outcomes (1)

• In-hospital mortality at the end of hospital discharge.

  6 months

Study Arms (1)

CT Perfusion

EXPERIMENTAL

Severe TBI patients will be undergoing CT perfusion test

Diagnostic Test: CT Perfusion

Interventions

CT Perfusion DIAGNOSTIC_TEST

Severe Traumatic Brain Injury patients will be undergoing CT perfusion test

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 the activation of the trauma code
• GCS score ≤ 8 after initial resuscitation
• On mechanical respiratory ventilation at the time of imaging

You may not qualify if:

• No known GCS after initial resuscitation
• Known pregnancy
• Known contraindication to CT contrast agent, e.g.,allergy or anaphylactic reaction
• Known end-stage renal disease stage 4-5 (eGFR \< 30 mL/min/1.73 m2)

Sponsors & Collaborators

• University of Manitoba: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (4)

Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

QEII Health Scienecs Centre

Halifax, Nova Scotia, B3K 4N1, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 0C1, Canada

Location

Related Publications (1)

• Alcock S, Batoo D, Ande SR, Grierson R, Essig M, Martin D, Trivedi A, Sinha N, Leeies M, Zeiler FA, Shankar JJS. Early diagnosis of mortality using admission CT perfusion in severe traumatic brain injury patients (ACT-TBI): protocol for a prospective cohort study. BMJ Open. 2021 Jun 9;11(6):e047305. doi: 10.1136/bmjopen-2020-047305.

  PMID: 34108167 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jai Shankar, MD FRCPC

  University of Manitoba

  PRINCIPAL INVESTIGATOR

• Frederick Zeiler, MD FRCPC

  University of Manitoba

  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: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 24, 2020
• Study Start: July 23, 2020
• Primary Completion: August 2, 2023
• Study Completion: August 2, 2023
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)