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Grant: Project Grant

Unity Health Toronto

$1,542,792.00

TRACE STUDY: An RCT using tranexamic acid in the treatment of subdural hematoma

FY 2021-22

Summary
Subdural hematoma (SDH) is a common condition experienced after head injury. Blood collects on the surface of the brain, causing headaches which can progress to confusion, weakness, or even coma. While surgery is the traditional treatment for SDH, not all patients require immediate treatment to ease pressure on the brain. After surgery, there can be up to 30% chance of more bleeding and the need for repeated surgery. Given this, a medicine capable of reducing the chance of further bleeding and speeding the recovery of the patient is highly desirable. In this study, we will conduct further testing of a commonly used, inexpensive drug called Tranexamic Acid (TXA). While the body stops unwanted and sometimes dangerous bleeding naturally by forming blood clots, TXA stops these blood clots from dissolving, thereby helping to keep bleeding spots plugged. Our pilot study showed that TXA helped speed up patients' recovery; but more rigorous testing on a larger number of patients is necessary to evaluate the effectiveness of TXA in reducing clinically important bleeding and at the same time confirm whether the drug can be used more widely to help improve patient outcomes. In this study, half of the patients will be randomly assigned to take TXA daily, while the other half will take a placebo, regardless of the need for surgery or not. We will assess patient-reported outcomes over time to quantify treatment success, while also taking biological samples, to better understand how this medicine works in SDH patients.
Program
Project Grant
Location
Ontario, Canada
Recipient Type
Other
Type
Grant
Source
CIHR Funding Decisions Database

As published

Id
453196
Name
Cusimano Michael D
Region
Ontario
Country
Canada
Orgtype
Institution Paid; Research Institution
Instname2
Neurosciences, Mental Health and Addiction
Theme2
Clinical
Prcname2
Randomized Controlled Trials
Projecttitle
TRACE STUDY: An RCT using tranexamic acid in the treatment of subdural hematoma
Programtype2
Operating Grants
Orgnameinp2
Unity Health Toronto
Cihramount2
$1,542,792
Cihrequipment2
$0
Programname2
Project Grant
Keyworddelim
Clinical Trial; Geriatrics; Machine Learning; Neuroimaging; Patient-Oriented Outcomes; Quality Of Life; Subdural Hematoma; Tranexamic Acid; Trauma; Traumatic Brain Injury
Abstract
Subdural hematoma (SDH) is a common condition experienced after head injury. Blood collects on the surface of the brain, causing headaches which can progress to confusion, weakness, or even coma. While surgery is the traditional treatment for SDH, not all patients require immediate treatment to ease pressure on the brain. After surgery, there can be up to 30% chance of more bleeding and the need for repeated surgery. Given this, a medicine capable of reducing the chance of further bleeding and speeding the recovery of the patient is highly desirable. In this study, we will conduct further testing of a commonly used, inexpensive drug called Tranexamic Acid (TXA). While the body stops unwanted and sometimes dangerous bleeding naturally by forming blood clots, TXA stops these blood clots from dissolving, thereby helping to keep bleeding spots plugged. Our pilot study showed that TXA helped speed up patients' recovery; but more rigorous testing on a larger number of patients is necessary to evaluate the effectiveness of TXA in reducing clinically important bleeding and at the same time confirm whether the drug can be used more widely to help improve patient outcomes. In this study, half of the patients will be randomly assigned to take TXA daily, while the other half will take a placebo, regardless of the need for surgery or not. We will assess patient-reported outcomes over time to quantify treatment success, while also taking biological samples, to better understand how this medicine works in SDH patients.
Competitiondate
202109
Approvedterm2
5 yrs 0 mth
Pinamesdelim
Cusimano, Michael D
Approvedterm
5 ans 0 mois
Cihrcontribution2
~ $1,542,792~ $0~