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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Niastase RT | Active Comparator | Niastase RT 80ug/kg IV bolus |
|
| Placebo | Placebo Comparator | saline IV bolus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rfVIIa | Biological | 80ug/kg IV bolus |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| ICH size | Difference between groups in ICH size on CT scan at 24 hours post-dose, adjusted for baseline ICH size | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility | Percentage of sites who can meet recruitment targets of 2 patients per site per year; % patients who meet the target time of <45 minutes from emergency department arrival to the start of the scan; % patients who meet the target time of <60 minutes from the end of the CT angiogram to administration of study drug; Local site spot sign interpretation accuracy as judged by central adjudicator; protocol violations |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| David J Gladstone, MD | Sunnybrook Health Sciences Centre | Principal Investigator |
| Richard Aviv, MD | Sunnybrook Health Sciences Centre | Principal Investigator |
| Andrew Demchuk, MD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre | Calgary | Alberta | T2N 2T9 | Canada | ||
| Walter C. Mackenzie Health Sciences Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36756899 | Derived | Al-Ajlan FS, Gladstone DJ, Song D, Thorpe KE, Swartz RH, Butcher KS, Del Campo M, Dowlatshahi D, Gensicke H, Lee GJ, Flaherty ML, Hill MD, Aviv RI, Demchuk AM; SPOTLIGHT Investigators. Time Course of Early Hematoma Expansion in Acute Spot-Sign Positive Intracerebral Hemorrhage: Prespecified Analysis of the SPOTLIGHT Randomized Clinical Trial. Stroke. 2023 Mar;54(3):715-721. doi: 10.1161/STROKEAHA.121.038475. Epub 2023 Feb 9. | |
| 31424491 |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D002543 | Cerebral Hemorrhage |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C103587 | recombinant FVIIa |
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| Standard saline solution | Other | Saline |
|
|
| 0 |
| Waiver of consent process evaluation/effectiveness | Waiver of consent use, acceptability, and effect on treatment times. Questionnaire will be administed to subject/LAR at 4 days and 90 days. | 4,90 days |
| Acute blood pressure control | % subjects where blood pressure control was acheived, defined as achieving systolic BP <180 mmHg within 1 hour post-randomization | 1hr |
| Thromboembolic events | Incidence of myocardial infarction and ischemic stroke within 4 days; any other arterial or venous thromboembolic SAEs within 4 days | 4 days |
| Mortality | 90-day mortality rate | 90 days |
| Unstable angina | Unstable angina w/in 4 days of treatment | 4 days |
| Troponin increase | Troponin rise above upper limit of normal within 4 days (without clinical symptoms or ECG evidence of acute coronary syndrome) | 4 days |
| DVT | Deep venous thrombosis (DVT) within 4 days | 4 days |
| Pulmonary embolism | PE within 30 days | 30 days |
| Cognition | Montreal Cognitive Assessment (MoCA) and Stroke Impact Scale at 90 days and 1 year. | 90 days, 1 year |
| Disability | Proportion of subjects with modified Rankin score 5-6 (death or severe disability) at 90 days and 1 year | 90 d, 1 year |
| Edmonton |
| Alberta |
| Canada |
| Vancouver General Hospital | Vancouver | British Columbia | V5Z 1N1 | Canada |
| Vancouver Island Health Authority | Victoria | British Columbia | V8R 1J8 | Canada |
| Hamilton HSC | Hamilton | Ontario | Canada |
| Kingston General Hospital | Kingston | Ontario | KZL 2V7 | Canada |
| London Health Sciences Centre | London | Ontario | Canada |
| Trillium Health Centre | Mississauga | Ontario | Canada |
| The Ottawa Hospital | Ottawa | Ontario | Canada |
| Toronto Western Hospital | Toronto | Ontario | M5T 2S8 | Canada |
| St. Michael's Hospital | Toronto | Ontario | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada |
| Hôpital Charles Le Moyne | Greenfield Park | Quebec | J4V 2H1 | Canada |
| Centre hospitalier de l'Université de Montréal | Montreal | Quebec | Canada |
| Montreal Neurological Institute | Montreal | Quebec | Canada |
| Derived |
| Gladstone DJ, Aviv RI, Demchuk AM, Hill MD, Thorpe KE, Khoury JC, Sucharew HJ, Al-Ajlan F, Butcher K, Dowlatshahi D, Gubitz G, De Masi S, Hall J, Gregg D, Mamdani M, Shamy M, Swartz RH, Del Campo CM, Cucchiara B, Panagos P, Goldstein JN, Carrozzella J, Jauch EC, Broderick JP, Flaherty ML; SPOTLIGHT and STOP-IT Investigators and Coordinators. Effect of Recombinant Activated Coagulation Factor VII on Hemorrhage Expansion Among Patients With Spot Sign-Positive Acute Intracerebral Hemorrhage: The SPOTLIGHT and STOP-IT Randomized Clinical Trials. JAMA Neurol. 2019 Dec 1;76(12):1493-1501. doi: 10.1001/jamaneurol.2019.2636. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D020300 | Intracranial Hemorrhages |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |