Status:
WITHDRAWN
Safety and Efficacy Study of Etanercept for Aneurysmal Subarachnoid Hemorrhage
Lead Sponsor:
Unity Health Toronto
Conditions:
Subarachnoid Hemorrhage, Aneurysmal
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 bleedin...
Detailed Description
SAH from a ruptured cerebral aneurysm has an incidence of 10 per 100,000 Canadians (over 3000 people annually). If a person survives SAH from a ruptured intracranial aneurysm, the most common complica...
Eligibility Criteria
Inclusion
- 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
- 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 condition or disease (e.g., known significant neurologic deficit, cancer, hematologic, or coronary disease), or chronic condition (e.g., psychiatric disorder), which, in the opinion of the investigator, would affect the assessment of the safety and tolerability of etanercept.
- Patients who have received an investigational product or participated in another clinical trial within 28 days prior to randomization or those who have already participated in the current study.
- History of hepatitis B or C, history of heart failure (etanercept may exacerbate heart failure), active infection or serious infection in the last 6 months, history of tuberculosis and history of malignancy, multiple sclerosis or history of seizures.
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01865630
Start Date
January 1 2021
End Date
January 1 2022
Last Update
November 2 2020
Active Locations (1)
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1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8