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

Active, not recruiting

Phase 2 Results N/A

Trial Description

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.

Conditions

Interventions

  • RfVIIa Biological
    Other Names: Niastase RT
    Intervention Desc: 80ug/kg IV bolus
    ARM 1: Kind: Experimental
    Label: Niastase RT
    Description: Niastase RT 80ug/kg IV bolus
  • Standard saline solution Other
    Other Names: Saline solution sourced from local hospital
    Intervention Desc: Saline
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: saline IV bolus

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary ICH size 24 hours No
Secondary Feasibility 0 No
Secondary Waiver of consent process evaluation/effectiveness 4,90 days No
Secondary Acute blood pressure control 1hr No
Secondary Thromboembolic events 4 days Yes
Secondary Mortality 90 days Yes
Secondary Unstable angina 4 days Yes
Secondary Troponin increase 4 days Yes
Secondary DVT 4 days Yes
Secondary Pulmonary embolism 30 days Yes
Secondary Cognition 90 days, 1 year No
Secondary Disability 90 d, 1 year Yes

Sponsors