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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01359202
Recruitment Status : Completed
First Posted : May 24, 2011
Last Update Posted : October 5, 2018
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Dr. David Gladstone, Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
Stroke Biological: rfVIIa Other: Standard saline solution Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: "Spot Sign" Selection of Intracerebral Hemorrhage to Guide Hemostatic Therapy: SPOTLIGHT
Actual Study Start Date : May 2011
Actual Primary Completion Date : June 30, 2018
Actual Study Completion Date : October 3, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Rashes

Arm Intervention/treatment
Active Comparator: Niastase RT
Niastase RT 80ug/kg IV bolus
Biological: rfVIIa
80ug/kg IV bolus
Other Name: Niastase RT

Placebo Comparator: Placebo
saline IV bolus
Other: Standard saline solution
Other Name: Saline solution sourced from local hospital

Primary Outcome Measures :
  1. ICH size [ Time Frame: 24 hours ]
    Difference between groups in ICH size on CT scan at 24 hours post-dose, adjusted for baseline ICH size

Secondary Outcome Measures :
  1. Feasibility [ Time Frame: 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

  2. Waiver of consent process evaluation/effectiveness [ Time Frame: 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.

  3. Acute blood pressure control [ Time Frame: 1hr ]
    % subjects where blood pressure control was acheived, defined as achieving systolic BP <180 mmHg within 1 hour post-randomization

  4. Thromboembolic events [ Time Frame: 4 days ]
    Incidence of myocardial infarction and ischemic stroke within 4 days; any other arterial or venous thromboembolic SAEs within 4 days

  5. Mortality [ Time Frame: 90 days ]
    90-day mortality rate

  6. Unstable angina [ Time Frame: 4 days ]
    Unstable angina w/in 4 days of treatment

  7. Troponin increase [ Time Frame: 4 days ]
    Troponin rise above upper limit of normal within 4 days (without clinical symptoms or ECG evidence of acute coronary syndrome)

  8. DVT [ Time Frame: 4 days ]
    Deep venous thrombosis (DVT) within 4 days

  9. Pulmonary embolism [ Time Frame: 30 days ]
    PE within 30 days

  10. Cognition [ Time Frame: 90 days, 1 year ]
    Montreal Cognitive Assessment (MoCA) and Stroke Impact Scale at 90 days and 1 year.

  11. Disability [ Time Frame: 90 d, 1 year ]
    Proportion of subjects with modified Rankin score 5-6 (death or severe disability) at 90 days and 1 year

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01359202

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Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Walter C. Mackenzie Health Sciences Centre
Edmonton, Alberta, Canada
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1N1
Vancouver Island Health Authority
Victoria, British Columbia, Canada, V8R 1J8
Canada, Ontario
Hamilton HSC
Hamilton, Ontario, Canada
Kingston General Hospital
Kingston, Ontario, Canada, KZL 2V7
London Health Sciences Centre
London, Ontario, Canada
Trillium Health Centre
Mississauga, Ontario, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
St. Michael's Hospital
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Canada, Quebec
Hôpital Charles Le Moyne
Greenfield Park, Quebec, Canada, J4V 2H1
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
Montreal Neurological Institute
Montreal, Quebec, Canada
Sponsors and Collaborators
Dr. David Gladstone
Canadian Institutes of Health Research (CIHR)
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Principal Investigator: 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
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dr. David Gladstone, Principal Investigator - Sponsor, Sunnybrook Health Sciences Centre Identifier: NCT01359202    
Other Study ID Numbers: Spotlight002
First Posted: May 24, 2011    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018
Keywords provided by Dr. David Gladstone, Sunnybrook Health Sciences Centre:
Intracerebral hemorrhage
acute stroke
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Intracranial Hemorrhages
Pharmaceutical Solutions