Grant: Operating Grant
Sunnybrook Research Institute (Toronto, Ontario)
$1,708,141.00
"Spot Sign" Selection of Intracerebral Hemorrhage to Guide Hemostatic Therapy (SPOTLIGHT): A Randomized Controlled Trial
FY 2009-10
Summary
This study tackles the problem of intracerebral hemorrhage, a serious type of stroke caused by bleeding into the brain from a ruptured blood vessel. It accounts for 10-30% of all strokes worldwide, often affecting young people, and is the deadliest, most disabling, and least treatable stroke type. Sadly, there are no proven emergency medical treatments available. We urgently need to develop an effective therapy and identify which patients will benefit most from treatment. The ideal treatment is one that can act quickly to stop bleeding and prevent hemorrhages from enlarging to a critical, life-threatening size. Now, an exciting treatment called "Factor 7", which has been used for years for other bleeding disorders, holds great promise for treating brain hemorrhages. Recently, "Factor 7" was shown to reduce the amount of bleeding in the brain by 58%! However, this did not translate into improved survival or reduced disability when given to a group of unselected patients. We believe this treatment will work best when given to a specific subgroup of brain hemorrhage patients that we call the "spot sign" patients. This study will test whether treatment in the emergency room with "Factor 7" is beneficial for brain hemorrhage patients who have a "spot sign" on brain scanning. A "spot sign" is detected by a contrast CT scan of the blood vessels in the head. Our group described this sign in 2007 as a bright dot within a hemorrhage, corresponding to leakage of contrast dye (extravasation) from a bleeding blood vessel. If a "spot sign" is present, it predicts a very high risk of worsening due to continued bleeding in the brain. About one-third of patients have a "spot sign" (indicating active bleeding) and two-thirds do not have a "spot sign" (indicating the bleeding has already stopped). Therefore, this sign should predict which patients will respond best to "Factor 7" therapy. If proven correct, this approach could revolutionize the management of hemorrhagic stroke.
Department
Program
Operating Grant
Location
Ontario, Canada
Type
Grant
Source
CIHR Funding Decisions Database
As published
Id
190251
Name
Gladstone David J
Region
Ontario
Country
Canada
Orgtype
Institution Paid; Research Institution
Instname2
Neurosciences, Mental Health and Addiction
Theme2
Clinical
Prcname2
Randomized Controlled Trials 2
Projecttitle
"Spot Sign" Selection of Intracerebral Hemorrhage to Guide Hemostatic Therapy (SPOTLIGHT): A Randomized Controlled Trial
Programtype2
Operating Grants
Orgnameinp2
Sunnybrook Research Institute (Toronto, Ontario)
Cihramount2
$1,708,141
Cihrequipment2
$0
Programname2
Operating Grant
Keyworddelim
Acute Stroke; Clinical; Hemostatic Therapy; Intracerebral Hemorrhage; Neuroimaging; Randomized Controlled Trial
Abstract
This study tackles the problem of intracerebral hemorrhage, a serious type of stroke caused by bleeding into the brain from a ruptured blood vessel. It accounts for 10-30% of all strokes worldwide, often affecting young people, and is the deadliest, most disabling, and least treatable stroke type. Sadly, there are no proven emergency medical treatments available. We urgently need to develop an effective therapy and identify which patients will benefit most from treatment. The ideal treatment is one that can act quickly to stop bleeding and prevent hemorrhages from enlarging to a critical, life-threatening size. Now, an exciting treatment called "Factor 7", which has been used for years for other bleeding disorders, holds great promise for treating brain hemorrhages. Recently, "Factor 7" was shown to reduce the amount of bleeding in the brain by 58%! However, this did not translate into improved survival or reduced disability when given to a group of unselected patients. We believe this treatment will work best when given to a specific subgroup of brain hemorrhage patients that we call the "spot sign" patients. This study will test whether treatment in the emergency room with "Factor 7" is beneficial for brain hemorrhage patients who have a "spot sign" on brain scanning. A "spot sign" is detected by a contrast CT scan of the blood vessels in the head. Our group described this sign in 2007 as a bright dot within a hemorrhage, corresponding to leakage of contrast dye (extravasation) from a bleeding blood vessel. If a "spot sign" is present, it predicts a very high risk of worsening due to continued bleeding in the brain. About one-third of patients have a "spot sign" (indicating active bleeding) and two-thirds do not have a "spot sign" (indicating the bleeding has already stopped). Therefore, this sign should predict which patients will respond best to "Factor 7" therapy. If proven correct, this approach could revolutionize the management of hemorrhagic stroke.
Competitiondate
200909
Approvedterm2
4 yrs 0 mth
Pinamesdelim
Gladstone, David J; Aviv, Richard; Demchuk, Andrew M
Approvedterm
4 ans 0 mois
Cihrcontribution2
~ $1,708,141~ $0~