Acetaminophen in aSAH to Inhibit Lipid Peroxidation and Cerebral Vasospasm

NCT00585559 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-04-18

Study results available
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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.

Conditions

  • Aneurysmal Subarachnoid Hemorrhage
  • Cerebral Vasospasm

Interventions

DRUG

Placebos for acetaminophen and N-acetylcysteine

Placebos for acetaminophen and N-acetylcysteine

DRUG

APAP 1 gm every 6 hours and N-acetylcysteine placebo

Acetaminophen 1 gm every 6 hours and N-acetylcysteine placebo

DRUG

NAC IV infusion at 0.5 gm hourly and APAP placebo

N-acetylcysteine IV infusion at 0.5 gm hourly and acetaminophen placebo

DRUG

APAP 1 gm q6 hours, plus NAC IV infusion at 0.5 gm hourly

Acetaminophen 1 gm every 6 hours, plus N-acetylcysteine IV infusion at 0.5 gm hourly

DRUG

APAP 1.5 gm q6 hours, plus NAC IV infusion at 0.5 gm hourly

Acetaminophen 1.5 gm every 6 hours, plus N-acetylcysteine IV infusion at 0.5 gm hourly

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH
  • National Institute of General Medical Sciences (NIGMS)

    collaborator NIH
  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Matthew Fusco, MD · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2023-10-26
Completion
2023-10-26

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00585559 on ClinicalTrials.gov