Overview

This trial is active, not recruiting.

Condition stroke
Treatments rfviia, standard saline solution
Phase phase 2
Sponsor Dr. David Gladstone
Collaborator Canadian Institutes of Health Research (CIHR)
Start date May 2011
End date May 2017
Trial size 50 participants
Trial identifier NCT01359202, Spotlight002

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Niastase RT 80ug/kg IV bolus
rfviia Niastase RT
80ug/kg IV bolus
(Placebo Comparator)
saline IV bolus
standard saline solution Saline solution sourced from local hospital
Saline

Primary Outcomes

Measure
ICH size
time frame: 24 hours

Secondary Outcomes

Measure
Feasibility
time frame: 0
Waiver of consent process evaluation/effectiveness
time frame: 4,90 days
Acute blood pressure control
time frame: 1hr
Thromboembolic events
time frame: 4 days
Mortality
time frame: 90 days
Unstable angina
time frame: 4 days
Troponin increase
time frame: 4 days
DVT
time frame: 4 days
Pulmonary embolism
time frame: 30 days
Cognition
time frame: 90 days, 1 year
Disability
time frame: 90 d, 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title "Spot Sign" Selection of Intracerebral Hemorrhage to Guide Hemostatic Therapy: SPOTLIGHT
Principal investigator David J Gladstone, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre.