Safety and Efficacy Study of Etanercept for Aneurysmal Subarachnoid Hemorrhage (NCT01865630) | Clinical Trial Compass
WithdrawnPhase 1
Safety and Efficacy Study of Etanercept for Aneurysmal Subarachnoid Hemorrhage
Stopped: PI moved to another institution
Canada0Started 2021-01
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female 18 to 75 years old.
* World Federation of Neurological Surgeons (WFNS) grade 2 to 4.
* Subarachnoid hemorrhage (SAH) on admission computed tomographic (CT) scan (diffuse clot present in both hemispheres or local thick SAH).
* Ruptured saccular aneurysm, confirmed by angiography (catheter or CT angiography \[CTA\]) and treated by neurosurgical clipping or endovascular coiling.
* External ventricular drain placed as part of routine care.
* Able to be dosed within 36 hours of injury
* Historical modified Rankin score of 0 or 1.
* Hemodynamically stable after resuscitation (systolic blood pressure \[SBP\] \> 100 mm Hg).
* Aminotransferase levels no greater than twice the upper limit of normal, hemoglobin \> 85 g/dL, platelets \> 125,000 cells/mm3, serum creatinine \< 177 μmol/L.
* Informed consent.
Exclusion Criteria:
* SAH due to causes other than saccular aneurysm (such as trauma or rupture of fusiform or infective aneurysm).
* Intraventricular or intracerebral hemorrhage, in the absence of SAH, or with only local, thin SAH.
* Angiographic vasospasm prior to clipping or endovascular procedure.
* Major complication during clipping or endovascular coiling, such as massive intraoperative hemorrhage, arterial occlusion or inability to clip or coil the ruptured aneurysm.
* Cardio-pulmonary resuscitation required following SAH.
* Women with a positive urine pregnancy test at screening.
* Body mass index \> 35
* Severe or unstable concomitant co…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety, blood brain barrier (BBB) permeability and potential efficacy of the TNFa antagonist, etanercept, in humans with subarachnoid hemorrhage (SAH).