"Spot Sign" Selection of Intracerebral Hemorrhage to Guide Hemostatic Therapy "SPOTLIGHT"

Active, not recruiting

Phase 2 Results N/A

Update History

25 Jun '16
A location was updated in Calgary.
New
The overall status was removed for Foothills Medical Centre.
A location was updated in Edmonton.
New
The overall status was removed for Walter C. Mackenzie Health Sciences Centre.
A location was updated in Vancouver.
New
The overall status was removed for Vancouver General Hospital.
A location was updated in Victoria.
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The overall status was removed for Vancouver Island Health Authority.
A location was updated in Hamilton.
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The overall status was removed for Hamilton HSC.
A location was updated in Kingston.
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The overall status was removed for Kingston General Hospital.
A location was updated in London.
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The overall status was removed for London Health Sciences Centre.
A location was updated in Mississauga.
New
The overall status was removed for Trillium Health Centre.
A location was updated in Ottawa.
New
The overall status was removed for The Ottawa Hospital.
A location was updated in Toronto.
New
The overall status was removed for Toronto Western Hospital.
A location was updated in Toronto.
New
The overall status was removed for St. Michael's Hospital.
A location was updated in Toronto.
New
The overall status was removed for Sunnybrook Health Sciences Centre.
A location was updated in Greenfield Park.
New
The overall status was removed for Hôpital Charles Le Moyne.
A location was updated in Montreal.
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The overall status was removed for Centre hospitalier de l'Université de Montréal.
A location was updated in Montreal.
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The overall status was removed for Montreal Neurological Institute.
9 Oct '15
The Summary of Purpose was updated.
New
This clinical trial will enroll 110 patients from approximately 15 Canadian stroke centres. Patients coming to the emergency department with bleeding in the brain not due to trauma or other known causes who can be treated within 6 hours of onset will undergo CT angiography using standard CT scanners ("CAT scan"). Those with a "spot sign", a type of marker on the CT scan that shows the brain is still bleeding, will be randomly assigned to a single injection of "factor 7"(a blood clotting drug used in hemophilia) or placebo (inactive saline); patients without a spot sign will not be treated. The researchers will look at how much bleeding happens after the treatments are administered, as well as clinical outcomes such as death and disability. The researchers think that factor 7 will cause the bleeding to stop faster and possibly decrease death and disability.
Old
This clinical trial will enroll 110 patients from approximately 15 Canadian stroke centres. Patients coming to the emergency department with bleeding in the brain not due to trauma or other known causes who can be treated within 6 hours of onset will undergo CT angiography using standard CT scanners ("CAT scan"). Those with a "spot sign", a type of marker on the CT scan that shows the brain is still bleeding, will be randomly assigned to a single injection of "factor 7"(a blood clotting drug used in hemophilia) or placebo (inactive saline); patients without a spot sign will not be treated. The researchers will look at how much bleeding happens after the treatments are administered, as well as clinical outcomes such as death and disability. The researchers think that factor 7 will cause the bleeding to stop faster and possibly decrease death and disability.
The description was updated.
New
This phase II double blind RCT will enroll 110 patients from approximately 15 Canadian stroke centres. Acute ICH patients who can be treated within 6 hours of onset will undergo CT angiography using standard CT procedures. Those with a spot sign will be randomly assigned in a 1:1 ratio to a single injection of rFVIIa 80 µg/kg or placebo; patients without a spot sign will not be treated. The primary endpoint is ICH expansion within 24 hours.
Old
This phase II double blind RCT will enroll 110 patients from approximately 15 Canadian stroke centres. Acute ICH patients who can be treated within 6 hours of onset will undergo CT angiography using standard CT procedures. Those with a spot sign will be randomly assigned in a 1:1 ratio to a single injection of rFVIIa 80 µg/kg or placebo; patients without a spot sign will not be treated. The primary endpoint is ICH expansion within 24 hours.
The eligibility criteria were updated.
New
Inclusion Criteria - Acute spontaneous primary supratentorial ICH diagnosed by CT scan. - Presence of a spot sign within the hematoma on CTA source images - Baseline ICH volume 3-90 ml - Age 18 or older - Investigator is able to randomize and administer study drug as soon as possible within a target of 60 minutes after CT angiogram and no later than 6 hours after stroke symptom onset (using the "last seen normal" principle). - Plan to provide full medical care for at least 24 hours - Assent-consent from patient or LAR prior to enrolment, or a waiver of consent (where REB approved) if patient/LAR assent-consent is not possible prior to enrolment. Exclusion Criteria - Brainstem or cerebellar hemorrhage. - ICH secondary to known or suspected trauma, aneurysm, vascular malformation, hemorrhagic conversion of ischemic stroke, venous sinus thrombosis, thrombolytic treatment, tumour, or infection; or an in-hospital ICH or ICH as a result of any in-hospital procedure or illness. - Baseline brain imaging shows evidence of acute or subacute ischemic stroke (chronic infarcts are not an exclusion). - Contrast administration within the previous 24 hours. - Evidence of thromboembolic risk factors, defined as any of the following: known history within the past 6 months of any of the following: (a) myocardial infarction, (b) coronary artery bypass surgery, (c) angina, (d) ischemic stroke, (e) transient ischemic attack, (f) carotid endarterectomy, (g) cerebral bypass surgery, (h) deep venous thrombosis, (i) pulmonary embolism, (j) any vascular angioplasty, stenting (coronary, peripheral vascular or cerebrovascular) or filter (e.g. vena cava filter);(k) prosthetic cardiac valve; and/or (l) known history of a high-risk thrombophilia (e.g. antithrombin III deficiency, antiphospholipid antibody syndrome, protein C deficiency, etc.) - Known hereditary (e.g. hemophilia) or acquired hemorrhagic diathesis or coagulation factor deficiency. - Any condition known that the investigator feels would pose a significant hazard if rFVIIa were administered. - Planned surgery for ICH within 24 hours (placement of intraventricular catheter is not an exclusion). - Planned withdrawal of care before 24 hours post-ICH onset. - Known participation in another therapeutic trial. - Known allergy or other contraindication to iodinated contrast dye. - Known or suspected hypersensitivity to the trial product. - Known unfractionated heparin use - must check PTT and exclude if elevated above upper limit of local lab's reference range. - Known low-molecular weight heparin, heparinoid, factor X inhibitor, or direct thrombin inhibitor use within previous 7 days. - Known GPIIb/IIIa antagonist use in previous 2 weeks. - Known warfarin (or other anticoagulant) therapy with INR >1.40. Note: if the patient is suspected to have cirrhosis, study staff are to wait for the INR value prior to dosing, and ensure not to enroll the patient if the INR value is >1.40. Otherwise the physician should use their discretion if they believe the patient is not at risk for elevated INR. - Concurrent or planned treatment with prothrombin complex concentrate, vitamin K, fresh frozen plasma, or platelet transfusion. - Pregnancy or lactation. Women of childbearing potential must have a negative pregnancy test prior to randomization. - Current clinical symptoms suggestive of acute coronary ischemia (e.g. chest pain). - Baseline ECG evidence of acute coronary ischemia (e.g. ST elevation in 2 contiguous leads, new LBBB, ST depression). - Baseline platelet count <50,000 or INR >1.40 or elevated PTT
Old
Inclusion Criteria - Acute spontaneous primary supratentorial ICH diagnosed by CT scan. - Presence of a spot sign within the hematoma on CTA source images - Baseline ICH volume 3-90 ml - Age 18 or older - Investigator is able to randomize and administer study drug as soon as possible within a target of 60 minutes after CT angiogram and no later than 6 hours after stroke symptom onset (using the "last seen normal" principle). - Plan to provide full medical care for at least 24 hours - Assent-consent from patient or LAR prior to enrolment, or a waiver of consent (where REB approved) if patient/LAR assent-consent is not possible prior to enrolment. Exclusion Criteria - Brainstem or cerebellar hemorrhage. - ICH secondary to known or suspected trauma, aneurysm, vascular malformation, hemorrhagic conversion of ischemic stroke, venous sinus thrombosis, thrombolytic treatment, tumour, or infection; or an in-hospital ICH or ICH as a result of any in-hospital procedure or illness. - Baseline brain imaging shows evidence of acute or subacute ischemic stroke (chronic infarcts are not an exclusion). - Contrast administration within the previous 24 hours. - Evidence of thromboembolic risk factors, defined as any of the following: known history within the past 6 months of any of the following: (a) myocardial infarction, (b) coronary artery bypass surgery, (c) angina, (d) ischemic stroke, (e) transient ischemic attack, (f) carotid endarterectomy, (g) cerebral bypass surgery, (h) deep venous thrombosis, (i) pulmonary embolism, (j) any vascular angioplasty, stenting (coronary, peripheral vascular or cerebrovascular) or filter (e.g. vena cava filter);(k) prosthetic cardiac valve; and/or (l) known history of a high-risk thrombophilia (e.g. antithrombin III deficiency, antiphospholipid antibody syndrome, protein C deficiency, etc.) - Known hereditary (e.g. hemophilia) or acquired hemorrhagic diathesis or coagulation factor deficiency. - Any condition known that the investigator feels would pose a significant hazard if rFVIIa were administered. - Planned surgery for ICH within 24 hours (placement of intraventricular catheter is not an exclusion). - Planned withdrawal of care before 24 hours post-ICH onset. - Known participation in another therapeutic trial. - Known allergy or other contraindication to iodinated contrast dye. - Known or suspected hypersensitivity to the trial product. - Known unfractionated heparin use - must check PTT and exclude if elevated above upper limit of local lab's reference range. - Known low-molecular weight heparin, heparinoid, factor X inhibitor, or direct thrombin inhibitor use within previous 7 days. - Known GPIIb/IIIa antagonist use in previous 2 weeks. - Known warfarin (or other anticoagulant) therapy with INR >1.40. Note: if the patient is suspected to have cirrhosis, study staff are to wait for the INR value prior to dosing, and ensure not to enroll the patient if the INR value is >1.40. Otherwise the physician should use their discretion if they believe the patient is not at risk for elevated INR. - Concurrent or planned treatment with prothrombin complex concentrate, vitamin K, fresh frozen plasma, or platelet transfusion. - Pregnancy or lactation. Women of childbearing potential must have a negative pregnancy test prior to randomization. - Current clinical symptoms suggestive of acute coronary ischemia (e.g. chest pain). - Baseline ECG evidence of acute coronary ischemia (e.g. ST elevation in 2 contiguous leads, new LBBB, ST depression). - Baseline platelet count <50,000 or INR >1.40 or elevated PTT
A location was updated in Montreal.
New
The overall status was removed for Montreal Neurological Institute.
22 Apr '14
The eligibility criteria were updated.
New
Inclusion Criteria - Acute spontaneous primary supratentorial ICH diagnosed by CT scan. - Presence of a spot sign within the hematoma on CTA source images - Baseline ICH volume 3-90 ml - Age 18 or older - Investigator is able to randomize and administer study drug as soon as possible within a target of 60 minutes after CT angiogram and no later than 6 hours after stroke symptom onset (using the "last seen normal" principle). - Plan to provide full medical care for at least 24 hours - Assent-consent from patient or LAR prior to enrolment, or a waiver of consent (where REB approved) if patient/LAR assent-consent is not possible prior to enrolment. Exclusion Criteria - Brainstem or cerebellar hemorrhage. - ICH secondary to known or suspected trauma, aneurysm, vascular malformation, hemorrhagic conversion of ischemic stroke, venous sinus thrombosis, thrombolytic treatment, tumour, or infection; or an in-hospital ICH or ICH as a result of any in-hospital procedure or illness. - Baseline brain imaging shows evidence of acute or subacute ischemic stroke (chronic infarcts are not an exclusion). - Contrast administration within the previous 24 hours. - Evidence of thromboembolic risk factors, defined as any of the following: known history within the past 6 months of any of the following: (a) myocardial infarction, (b) coronary artery bypass surgery, (c) angina, (d) ischemic stroke, (e) transient ischemic attack, (f) carotid endarterectomy, (g) cerebral bypass surgery, (h) deep venous thrombosis, (i) pulmonary embolism, (j) any vascular angioplasty, stenting (coronary, peripheral vascular or cerebrovascular) or filter (e.g. vena cava filter);(k) prosthetic cardiac valve; and/or (l) known history of a high-risk thrombophilia (e.g. antithrombin III deficiency, antiphospholipid antibody syndrome, protein C deficiency, etc.) - Known hereditary (e.g. hemophilia) or acquired hemorrhagic diathesis or coagulation factor deficiency. - Any condition known that the investigator feels would pose a significant hazard if rFVIIa were administered. - Planned surgery for ICH within 24 hours (placement of intraventricular catheter is not an exclusion). - Planned withdrawal of care before 24 hours post-ICH onset. - Known participation in another therapeutic trial. - Known allergy or other contraindication to iodinated contrast dye. - Known or suspected hypersensitivity to the trial product. - Known unfractionated heparin use - must check PTT and exclude if elevated above upper limit of local lab's reference range. - Known low-molecular weight heparin, heparinoid, factor X inhibitor, or direct thrombin inhibitor use within previous 7 days. - Known GPIIb/IIIa antagonist use in previous 2 weeks. - Known warfarin (or other anticoagulant) therapy with INR >1.40. Note: if the patient is suspected to have cirrhosis, study staff are to wait for the INR value prior to dosing, and ensure not to enroll the patient if the INR value is >1.40. Otherwise the physician should use their discretion if they believe the patient is not at risk for elevated INR. - Concurrent or planned treatment with prothrombin complex concentrate, vitamin K, fresh frozen plasma, or platelet transfusion. - Pregnancy or lactation. Women of childbearing potential must have a negative pregnancy test prior to randomization. - Current clinical symptoms suggestive of acute coronary ischemia (e.g. chest pain). - Baseline ECG evidence of acute coronary ischemia (e.g. ST elevation in 2 contiguous leads, new LBBB, ST depression). - Baseline platelet count <50,000 or INR >1.40 or elevated PTT
Old
Inclusion Criteria - Acute spontaneous primary supratentorial ICH diagnosed by CT scan. - Presence of a spot sign within the hematoma on CTA source images - Baseline ICH volume 3-70 ml - Age 18-85 years - Investigator is able to randomize and administer study drug within 60 minutes after CT angiogram and no later than 6 hours after stroke symptom onset (using the "last seen normal" principle). - Assent-consent from patient or LAR prior to enrolment, or a waiver of consent if patient/LAR assent-consent is not possible prior to enrolment. Exclusion Criteria - Brainstem or cerebellar hemorrhage. - ICH secondary to known or suspected trauma, aneurysm, vascular malformation, hemorrhagic conversion of ischemic stroke, venous sinus thrombosis, thrombolytic treatment, tumour, or infection; or an in-hospital ICH or ICH as a result of any in-hospital procedure or illness. - Baseline brain imaging shows evidence of acute or subacute ischemic stroke (chronic infarcts are not an exclusion). - Contrast administration within the previous 24 hours. - Glasgow Coma Scale score <8, at time of initial screening by the enrolling investigator/nurse. - Known pre-existing dependence or moderate or severe disability, defined as pre-admission modified Rankin Scale score >2 - Evidence of thromboembolic risk factors, defined as any of the following: known history within the past 6 months of any of the following: (a) myocardial infarction, (b) coronary artery bypass surgery, (c) angina, (d) ischemic stroke, (e) transient ischemic attack, (f) carotid endarterectomy, (g) cerebral bypass surgery, (h) deep venous thrombosis, (i) pulmonary embolism, (j) any vascular angioplasty, stenting (coronary, peripheral vascular or cerebrovascular) or filter (e.g. vena cava filter); and/or known history of a high-risk thrombophilia (e.g. antithrombin III deficiency, antiphospholipid antibody syndrome, protein C deficiency, etc.) - Known hereditary (e.g. hemophilia) or acquired hemorrhagic diathesis or coagulation factor deficiency. - Any condition known that the investigator feels would pose a significant hazard if rFVIIa were administered. - Planned surgery for ICH within 24 hours (placement of intraventricular catheter is not an exclusion). - Known terminal illness or planned withdrawal of care or comfort care measures. - Known participation in another therapeutic trial. - Known allergy or other contraindication to iodinated contrast dye. - Known or suspected hypersensitivity to the trial product. - Known unfractionated heparin use - must check PTT and exclude if elevated above upper limit of local lab's reference range. - Known low-molecular weight heparin, heparinoid, factor X inhibitor, or direct thrombin inhibitor use within previous 24 hours. - Known GPIIb/IIIa antagonist use in previous 2 weeks. - Known warfarin (or other anticoagulant) therapy with INR >1.40. Note: if the patient is suspected to have cirrhosis, study staff are to wait for the INR value prior to dosing, and ensure not to enroll the patient if the INR value is >1.40. Otherwise the physician should use their discretion if they believe the patient is not at risk for elevated INR. - Concurrent or planned treatment with prothrombin complex concentrate, vitamin K, fresh frozen plasma, or platelet transfusion. - Pregnancy or lactation. Women of childbearing potential must have a negative pregnancy test prior to randomization. - Current clinical symptoms suggestive of acute coronary ischemia (e.g. chest pain). - Baseline ECG evidence of acute coronary ischemia (e.g. ST elevation in 2 contiguous leads, new LBBB, ST depression). - Baseline troponin T or troponin I >0.1 ng/ml (>0.1 µg/L). - Baseline platelet count <50,000 or INR >1.40 or elevated PTT
28 Mar '14
A location was updated in London.
New
The overall status was removed for London Health Sciences Centre.
A location was updated in Montreal.
New
The overall status was removed for Centre hospitalier de l'Université de Montréal.
15 Jan '13
A location was updated in Mississauga.
New
The overall status was updated to "Recruiting" at Trillium Health Centre.
17 Oct '12
A location was updated in Greenfield Park.
New
The overall status was removed for Hôpital Charles Le Moyne.
11 Jul '12
A location was updated in Ottawa.
New
The overall status was updated to "Recruiting" at The Ottawa Hospital.
A location was updated in Toronto.
New
The overall status was removed for St. Michael's Hospital.
7 Apr '12
A location was updated in Edmonton.
New
The overall status was updated to "Recruiting" at Walter C. Mackenzie Health Sciences Centre.
A location was updated in Hamilton.
New
The overall status was updated to "Recruiting" at Hamilton HSC.
A location was updated in Toronto.
New
The overall status was removed for Toronto Western Hospital.
9 Feb '12
A location was updated in Calgary.
New
The overall status was removed for Foothills Medical Centre.