"Spot Sign" Selection of Intracerebral Hemorrhage to Guide Hemostatic Therapy
- Conditions
- Stroke
- Interventions
- Other: Standard saline solutionBiological: rfVIIa
- Registration Number
- NCT01359202
- Lead Sponsor
- Dr. David Gladstone
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Standard saline solution saline IV bolus Niastase RT rfVIIa Niastase RT 80ug/kg IV bolus
- Primary Outcome Measures
Name Time Method ICH size 24 hours Difference between groups in ICH size on CT scan at 24 hours post-dose, adjusted for baseline ICH size
- Secondary Outcome Measures
Name Time Method DVT 4 days Deep venous thrombosis (DVT) within 4 days
Thromboembolic events 4 days Incidence of myocardial infarction and ischemic stroke within 4 days; any other arterial or venous thromboembolic SAEs within 4 days
Mortality 90 days 90-day mortality rate
Unstable angina 4 days Unstable angina w/in 4 days of treatment
Troponin increase 4 days Troponin rise above upper limit of normal within 4 days (without clinical symptoms or ECG evidence of acute coronary syndrome)
Feasibility 0 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
Waiver of consent process evaluation/effectiveness 4,90 days Waiver of consent use, acceptability, and effect on treatment times. Questionnaire will be administed to subject/LAR at 4 days and 90 days.
Acute blood pressure control 1hr % subjects where blood pressure control was acheived, defined as achieving systolic BP \<180 mmHg within 1 hour post-randomization
Cognition 90 days, 1 year Montreal Cognitive Assessment (MoCA) and Stroke Impact Scale at 90 days and 1 year.
Pulmonary embolism 30 days PE within 30 days
Disability 90 d, 1 year Proportion of subjects with modified Rankin score 5-6 (death or severe disability) at 90 days and 1 year
Trial Locations
- Locations (15)
Hamilton HSC
🇨🇦Hamilton, Ontario, Canada
Kingston General Hospital
🇨🇦Kingston, Ontario, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Trillium Health Centre
🇨🇦Mississauga, Ontario, Canada
Toronto Western Hospital
🇨🇦Toronto, Ontario, Canada
The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
St. Michael's Hospital
🇨🇦Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Foothills Medical Centre
🇨🇦Calgary, Alberta, Canada
Centre hospitalier de l'Université de Montréal
🇨🇦Montreal, Quebec, Canada
Hôpital Charles Le Moyne
🇨🇦Greenfield Park, Quebec, Canada
Montreal Neurological Institute
🇨🇦Montreal, Quebec, Canada
Walter C. Mackenzie Health Sciences Centre
🇨🇦Edmonton, Alberta, Canada
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Vancouver Island Health Authority
🇨🇦Victoria, British Columbia, Canada