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StrokePhase 2SPOTLIGHTNCT01359202

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

A Phase 2 study testing rfVIIa and Standard saline solution in people with Stroke, run by Dr. David Gladstone at 15 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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"). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke
What is being tested?
rfVIIa and Standard saline solution
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
15 sitesCanada
Study dates
May 2011to 3 Oct 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Canada15 sites

  • Foothills Medical Centre

    Calgary, Alberta, T2N 2T9

  • Walter C. Mackenzie Health Sciences Centre

    Edmonton, Alberta

  • Hôpital Charles Le Moyne

    Greenfield Park, Quebec, J4V 2H1

  • Hamilton HSC

    Hamilton, Ontario

  • Kingston General Hospital

    Kingston, Ontario, KZL 2V7

  • London Health Sciences Centre

    London, Ontario

  • Trillium Health Centre

    Mississauga, Ontario

  • Centre hospitalier de l'Université de Montréal

    Montreal, Quebec

  • Montreal Neurological Institute

    Montreal, Quebec

  • The Ottawa Hospital

    Ottawa, Ontario

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8

  • St. Michael's Hospital

    Toronto, Ontario

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z 1N1

  • Vancouver Island Health Authority

    Victoria, British Columbia, V8R 1J8

Other trials in Canada

About this study

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

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.

Read the 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.

Conditions
Stroke
Being tested
rfVIIa, Standard saline solution
Keywords
Stroke, ICH, Intracerebral hemorrhage, acute stroke, rfVIIa, Niastase
Medical subject headings
Stroke, Cerebral Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • rfVIIaBiological

    Also called Niastase RT

    80ug/kg IV bolus

  • Standard saline solutionOther

    Also called Saline solution sourced from local hospital

    Saline

Study groups in NCT01359202
Study groupRoleWhat they receive
Niastase RTActive comparatorNiastase RT 80ug/kg IV bolus
Receives: Biological: rfVIIa
PlaceboPlacebo comparatorsaline IV bolus
Receives: Other: Standard saline solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ICH size

    Difference between groups in ICH size on CT scan at 24 hours post-dose, adjusted for baseline ICH size

    Measured: 24 hours

Secondary outcomes (11)

  1. 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

    Measured: 0

  2. 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.

    Measured: 4,90 days

  3. Acute blood pressure control

    % subjects where blood pressure control was acheived, defined as achieving systolic BP <180 mmHg within 1 hour post-randomization

    Measured: 1hr

  4. Thromboembolic events

    Incidence of myocardial infarction and ischemic stroke within 4 days; any other arterial or venous thromboembolic SAEs within 4 days

    Measured: 4 days

  5. Mortality

    90-day mortality rate

    Measured: 90 days

  6. Unstable angina

    Unstable angina w/in 4 days of treatment

    Measured: 4 days

  7. Troponin increase

    Troponin rise above upper limit of normal within 4 days (without clinical symptoms or ECG evidence of acute coronary syndrome)

    Measured: 4 days

  8. DVT

    Deep venous thrombosis (DVT) within 4 days

    Measured: 4 days

  9. Pulmonary embolism

    PE within 30 days

    Measured: 30 days

  10. Cognition

    Montreal Cognitive Assessment (MoCA) and Stroke Impact Scale at 90 days and 1 year.

    Measured: 90 days, 1 year

  11. Disability

    Proportion of subjects with modified Rankin score 5-6 (death or severe disability) at 90 days and 1 year

    Measured: 90 d, 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2011 (estimated)
  2. Study startMay 2011
  3. Primary completion30 Jun 2018
  4. Study completion3 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01359202
Sponsor's protocol ID
Spotlight002
Acronym
SPOTLIGHT
Status last verified
Oct 2018
First submitted
20 May 2011
Last updated
5 Oct 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 36756899

  • 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.

    PubMed 31424491

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rfVIIa and Standard saline solution in people with Stroke, run by Dr. David Gladstone at 15 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ICH size (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01359202, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2018.

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