Acetaminophen in aSAH to Inhibit Lipid Peroxidation and Cerebral Vasospasm (NCT00585559) | Clinical Trial Compass
TerminatedPhase 3
Acetaminophen in aSAH to Inhibit Lipid Peroxidation and Cerebral Vasospasm
United States44 participantsStarted 2007-04
Plain-language summary
The objective of this study is to determine whether acetaminophen (APAP), N-acetylcysteine (NAC), and APAP in combination with NAC will inhibit lipid peroxidation in aneurysmal subarachnoid hemorrhage (aSAH), utilizing F2-IsoPs as biomarkers for lipid peroxidation.
Who can participate
Age range
20 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:
* Ages ≥ 20
* Fisher Grade III or III + IV SAH based upon admitting CT scan
* Aneurysm secured by either clipping or coiling within 72 hours of SAH
* Intracranial aneurysm confirmed by angiography or CTA
* Presence of ventriculostomy for external ventricular drainage (EVD) prior to randomization
Exclusion Criteria:
* Consent unobtainable
* Enrollment in another interventional study
* Patient is pregnant or lactating
* Known co-morbidities that could affect outcome of this study
* Contraindication to CTA
* Serum creatinine \> 1.4
* Documented allergy to iodinated contrast that cannot be adequately treated with premedication
* Documented allergy and/or intolerance to ApAP
* Baseline liver disease
* History of recent alcohol abuse with documented ALT or AST above normal laboratory values
* Documented history of both malnutrition and decreased serum albumin below normal lab values
* Documented abnormal platelet count below normal lab values
* Documented abnormal PT or PTT above normal lab values
* History or evidence of active asthma
* Documented allergy and/or intolerance to N-acetylcysteine
* Currently taking phenytoin, carbamazepine, or phenobarbital
* Currently taking isoniazid (INH, Lanzid, Nydrazid)
* Severe life-threatening complications resulting from standard aneurysm treatments that will likely prevent completion of the study
* Patient unsuitable for the study, in the opinion of the investigator(s)
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
Number of Patients With Vasospasm Based on Magnetic Resonance Angiography (MRA)
Timeframe: 8 Days post subarachnoid hemorrhage (SAH) event
2
Number of Patients With Vasospasm Based on Computed Tomographic Angiography (CTA)
Timeframe: 8 Days post subarachnoid hemorrhage (SAH) event
3
National Institutes of Health Stroke Scale (NIHSS) Score
Timeframe: 8 Days post subarachnoid hemorrhage (SAH) event
4
Modified Rankin Scale (MRS) Score
Timeframe: 8 Days post subarachnoid hemorrhage (SAH) event
5
Glasgow Outcome Scale (GOS) Score
Timeframe: 8 Days post subarachnoid hemorrhage (SAH) event
6
The Barthel Index Score
Timeframe: 8 Days post subarachnoid hemorrhage (SAH) event