Acetaminophen in aSAH to Inhibit Lipid Peroxidation and Cerebral Vasospasm

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University Medical Center
• Collaborators: National Institute of General Medical Sciences (NIGMS); National Institutes of Health (NIH)
• Treatments: Acetaminophen; Acetylcysteine; N-monoacetylcystine

Criteria

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)