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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04318665
Recruitment Status : Not yet recruiting
First Posted : March 24, 2020
Last Update Posted : March 30, 2020
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Jai Shankar, University of Manitoba

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.


Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Diagnostic Test: CT Perfusion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Early Diagnosis of Mortality Using Admission CT Perfusion in Severe Traumatic Brain Injury Patients (ACT-TBI Study)
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CT Perfusion
Severe TBI patients will be undergoing CT perfusion test
Diagnostic Test: CT Perfusion
Severe Traumatic Brain Injury patients will be undergoing CT perfusion test




Primary Outcome Measures :
  1. The primary outcome is a binary outcome of mortality ('dead') or survival ('not-dead') in the first 48 hours of hospital admission. [ Time Frame: 48 hours ]
    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.


Secondary Outcome Measures :
  1. In-hospital mortality at the end of hospital discharge. [ Time Frame: 6 months ]
    the secondary outcome of this study is to determine In-hospital mortality at the end of hospital discharge.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04318665


Contacts
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Contact: Jai Shankar, MD FRCPC 431 373 4164 shivajai1@gmail.com
Contact: Sudharsana R Ande, PhD 204 789 3996 sudarshanande@yahoo.com

Locations
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Canada, Manitoba
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9
Contact: Jai Shankar, MD FRCPC    431 373 4164    shivajai1@gmail.com   
Principal Investigator: Jai Shankar, MD FRCPC         
Principal Investigator: Frederick Zeiler, MD FRCPC         
Canada, Nova Scotia
QEII Health Scienecs Centre
Halifax, Nova Scotia, Canada, B3K 4N1
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9
Contact: Santanu Chakraborty, MD FRCPC         
Canada, Quebec
Centre hospitalier de l'Université de Montréal (CHUM)
Montréal, Quebec, Canada, H2X 0C1
Contact: Daniela Iancu, MD FRCPC         
Sponsors and Collaborators
University of Manitoba
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Jai Shankar, MD FRCPC University of Manitoba
Principal Investigator: Frederick Zeiler, MD FRCPC University of Manitoba
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Responsible Party: Jai Shankar, Professor, University of Manitoba
ClinicalTrials.gov Identifier: NCT04318665    
Other Study ID Numbers: HS23683 (B2020:018)
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jai Shankar, University of Manitoba:
TBI, CTP
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System