NCT01359202

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2 stroke

Timeline
Completed

Started May 2011

Longer than P75 for phase_2 stroke

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 24, 2011

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2018

Completed
Last Updated

October 5, 2018

Status Verified

October 1, 2018

Enrollment Period

7.2 years

First QC Date

May 20, 2011

Last Update Submit

October 3, 2018

Conditions

Stroke

Keywords

StrokeICHIntracerebral hemorrhageacute strokerfVIIaNiastase

Outcome Measures

Primary Outcomes (1)

  • ICH size

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

    24 hours

Secondary Outcomes (11)

  • Feasibility

    0

  • Waiver of consent process evaluation/effectiveness

    4,90 days

  • Acute blood pressure control

    1hr

  • Thromboembolic events

    4 days

  • Mortality

    90 days

  • +6 more secondary outcomes

Study Arms (2)

Niastase RT

ACTIVE COMPARATOR

Niastase RT 80ug/kg IV bolus

Biological: rfVIIa

Placebo

PLACEBO COMPARATOR

saline IV bolus

Other: Standard saline solution

Interventions

rfVIIaBIOLOGICAL

80ug/kg IV bolus

Also known as: Niastase RT
Niastase RT
Standard saline solutionOTHER

Saline

Also known as: Saline solution sourced from local hospital
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Walter C. Mackenzie Health Sciences Centre

Edmonton, Alberta, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1N1, Canada

Location

Vancouver Island Health Authority

Victoria, British Columbia, V8R 1J8, Canada

Location

Hamilton HSC

Hamilton, Ontario, Canada

Location

Kingston General Hospital

Kingston, Ontario, KZL 2V7, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

Trillium Health Centre

Mississauga, Ontario, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, Canada

Location

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Location

Hôpital Charles Le Moyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, Canada

Location

Montreal Neurological Institute

Montreal, Quebec, Canada

Location

Related Publications (2)

  • 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.

    PMID: 36756899DERIVED

  • 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.

    PMID: 31424491DERIVED

MeSH Terms

Conditions

StrokeCerebral Hemorrhage

Interventions

recombinant FVIIa

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesIntracranial HemorrhagesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator - Sponsor

Study Record Dates

First Submitted

May 20, 2011

First Posted

May 24, 2011

Study Start

May 1, 2011

Primary Completion

June 30, 2018

Study Completion

October 3, 2018

Last Updated

October 5, 2018

Record last verified: 2018-10

Locations

CA(15)