Early Diagnosis of Mortality Using Admission CT Perfusion in Severe Traumatic Brain Injury Patients (ACT-TBI Study) (ACT-TBI)
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|ClinicalTrials.gov Identifier: NCT04318665|
Recruitment Status : Not yet recruiting
First Posted : March 24, 2020
Last Update Posted : March 30, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
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
|Contact: Jai Shankar, MD FRCPC||431 373 firstname.lastname@example.org|
|Contact: Sudharsana R Ande, PhD||204 789 email@example.com|
|Health Sciences Centre|
|Winnipeg, Manitoba, Canada, R3A 1R9|
|Contact: Jai Shankar, MD FRCPC 431 373 4164 firstname.lastname@example.org|
|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|
|The Ottawa Hospital|
|Ottawa, Ontario, Canada, K1Y 4E9|
|Contact: Santanu Chakraborty, MD FRCPC|
|Centre hospitalier de l'Université de Montréal (CHUM)|
|Montréal, Quebec, Canada, H2X 0C1|
|Contact: Daniela Iancu, MD FRCPC|
|Principal Investigator:||Jai Shankar, MD FRCPC||University of Manitoba|
|Principal Investigator:||Frederick Zeiler, MD FRCPC||University of Manitoba|