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

Stroke Clinical Trial

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

Status Completed

Clinical 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"). 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Stroke

• NCT number: NCT01359202
• Study type: Interventional
• Source: Sunnybrook Health Sciences Centre
• Status: Completed
• Phase: Phase 2
• Start date: May 2011
• Completion date: October 3, 2018