Safety and Efficacy Study of Etanercept for Aneurysmal Subarachnoid Hemorrhage
Status:
Withdrawn
Trial end date:
2022-01-01
Target enrollment:
Participant gender:
Summary
Subarachnoid hemorrhage (SAH) is a special type of stroke that typically results from a
ruptured intracranial aneurysm, a weakening in the wall of a blood vessel. This type of
life-threatening bleeding occurs in over 3000 Canadians per year, usually in working age
adults. Although this type of stroke accounts for only 5-10% of strokes, it contributes a
disproportionately larger percent of overall stroke morbidity and mortality due in part to
the young age of those affected. If one is fortunate enough to survive the initial bleeding
episode and the subsequent surgical treatment of the aneurysm, a patient may still develop
secondary strokes 3 to 14 days after the initial bleed. These delayed strokes are the most
significant cause of morbidity and mortality after SAH and may be potentially preventable.
Currently, there is only one medication (an anti-hypertensive) that has convincingly shown to
improve outcomes after SAH. The molecular pathway causing these delayed strokes is still not
clear, and this is an active area of research.
Animal studies have revealed that these delayed strokes may be caused by a pro-inflammation
molecule called tumor necrosis factor alpha (TNFa). Delayed strokes were prevented
experimentally by a TNFa blocker called etanercept. This clinical study, utilizing
prophylactic treatment with etanercept in patients with SAH, will ensure the safety of this
drug and determine its effectiveness in preventing delayed strokes.
Phase:
Phase 1
Details
Lead Sponsor:
St. Michael's Hospital, Toronto Unity Health Toronto