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Analgesic
Acetaminophen + N-acetylcysteine for Subarachnoid Hemorrhage
Phase 3
Waitlist Available
Led By Matthew Fusco, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 21 days
Awards & highlights
Study Summary
This trial is testing whether acetaminophen, N-acetylcysteine, or a combination of the two can help reduce lipid peroxidation in people who have had a subarachnoid hemorrhage.
Who is the study for?
This trial is for adults over 20 with a specific type of brain hemorrhage (Fisher Grade III or IV SAH) who've had their aneurysm secured within 72 hours. They must have a ventriculostomy and cannot be pregnant, in another study, have certain health issues like liver disease, high creatinine levels, allergies to APAP/NAC, alcohol abuse, malnutrition with low albumin levels, abnormal blood counts or clotting times.Check my eligibility
What is being tested?
The study tests if acetaminophen (APAP), N-acetylcysteine (NAC), or both can prevent lipid damage in the brain after subarachnoid hemorrhage using biomarkers. Participants will receive different combinations of APAP and NAC versus placebos to see which treatment is most effective.See study design
What are the potential side effects?
Possible side effects include allergic reactions to either APAP or NAC, potential liver issues from APAP especially at higher doses or when combined with alcohol use; NAC may cause nausea, vomiting and more rarely asthma-like symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 21 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~21 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The study is to determine whether APAP, NAC, and APAP with NAC will inhibit lipid peroxidation in (aSAH), utilizing F2-IsoPs as biomarkers for lipid peroxidation. The effect on the F2-IsoPs will be the primary study endpoint.
Secondary outcome measures
To determine whether APAP and APAP with NAC will inhibit vasospasm and brain ischemia in aSAH, as assessed by CTA w/perfusion imaging or MRI and diffusion weighted images.
Trial Design
5Treatment groups
Active Control
Placebo Group
Group I: Acetaminophen and N-acetylcysteine placeboActive Control1 Intervention
Acetaminophen 1 gm every 6 hours and N-acetylcysteine placebo
Group II: N-acetylcysteine and acetaminophenActive Control1 Intervention
N-acetylcysteine IV infusion at 0.5 gm hourly and acetaminophen placebo
Group III: Acetaminophen 1 Gram and N-acetylcysteineActive Control1 Intervention
Acetaminophen 1 gm every 6 hours, plus N-acetylcysteine IV infusion at 0.5 gm hourly
Group IV: Acetaminophen 1.5 Gram and N-acetylcysteineActive Control1 Intervention
Acetaminophen 1.5 gm every 6 hours, plus N-acetylcysteine IV infusion at 0.5 gm hourly
Group V: Placebos for acetaminophen and N-acetylcysteinePlacebo Group1 Intervention
Placebos for acetaminophen and N-acetylcysteine
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Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,072 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,459 Total Patients Enrolled
National Institute of General Medical Sciences (NIGMS)NIH
268 Previous Clinical Trials
248,640 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a medical reason that makes it unsafe for you to receive contrast material for imaging tests.Your blood test shows high levels of creatinine.You have a known allergy or can't tolerate ApAP.You have a liver disease before starting the trial.You have been drinking a lot of alcohol recently, and your liver tests show that there may be a problem.You have a history of not getting enough nutrients and having low albumin levels in your blood.Your blood platelet count is lower than the normal range.Your blood clotting tests show abnormal results.You have current or past issues with asthma.You have a known allergy or intolerance to N-acetylcysteine.You are currently taking phenytoin, carbamazepine, or phenobarbital.You are currently taking a medication called isoniazid.You have serious and life-threatening complications from standard treatments for an aneurysm that could stop you from finishing the study.You have severe bleeding in the brain based on a CT scan.You had surgery to fix an aneurysm within 72 hours of a stroke caused by bleeding in the brain.You have been diagnosed with a bulging blood vessel in your brain.You are 20 years old or older.You have a known allergy to iodinated contrast that cannot be managed with premedication.You have a ventriculostomy for external ventricular drainage before the study starts.
Research Study Groups:
This trial has the following groups:- Group 1: Placebos for acetaminophen and N-acetylcysteine
- Group 2: Acetaminophen and N-acetylcysteine placebo
- Group 3: N-acetylcysteine and acetaminophen
- Group 4: Acetaminophen 1 Gram and N-acetylcysteine
- Group 5: Acetaminophen 1.5 Gram and N-acetylcysteine
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people have volunteered to take part in this research?
"Although this study was last updated on 10/17/2022, it is not presently looking for new participants. However, there are other clinical trials that may be of interest. There are 391 studies actively enrolling patients with vasospasm, cerebral and 136 Acetaminophen 1 Gram and N-acetylcysteine trials that still need participants."
Answered by AI
Is it legal to prescribe Acetaminophen 1 Gram and N-acetylcysteine?
"Acetaminophen 1 Gram and N-acetylcysteine have both Phase 3 clinical data supporting their efficacy and safety."
Answered by AI
Are patients being recruited for this research project at this time?
"Unfortunately, this study is not currently looking for participants. As reported on clinicaltrials.gov, the trial was first posted over 15 years ago and was last updated almost 5 years ago. Although this study isn't recruiting patients right now, there are 527 other studies that are actively searching for volunteers."
Answered by AI
Are there any other trials that have looked at the effects of Acetaminophen 1 Gram and N-acetylcysteine?
"As of now, there are a total of 136 research studies being conducted that involve Acetaminophen 1 Gram and N-acetylcysteine. Of those trials, 34 are currently in Phase 3. The majority of these Acetaminophen 1 Gram and N-acetylcysteine studies are taking place in São Paulo, but there are 1050 different locations worldwide where these treatments are being tested."
Answered by AI
What do Acetaminophen 1 Gram and N-acetylcysteine help alleviate?
"The standard course of treatment for catarrh includes acetaminophen 1 Gram and N-acetylcysteine. This medication can also be used to relieve rhinorrhoea, musculoskeletal pain, and muscle spasms."
Answered by AI
Who else is applying?
What state do they live in?
Tennessee
How old are they?
18 - 65
What site did they apply to?
Tristar Skyline Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
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