Trial · NCT00585559
Acetaminophen in aSAH to Inhibit Lipid Peroxidation and Cerebral Vasospasm
NCT00585559, Phase 3, Terminated, Vanderbilt University Medical Center; results first posted 2025-04-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Acetaminophen in aSAH to Inhibit Lipid Peroxidation and Cerebral Vasospasm. Trials, record NCT00585559. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00585559
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Acetaminophen in aSAH to Inhibit Lipid Peroxidation and Cerebral Vasospasm
- NCT number
- NCT00585559
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 44 participants, actual
- Lead sponsor
- Vanderbilt University Medical Center
- Conditions
- Aneurysmal Subarachnoid Hemorrhage, Cerebral Vasospasm
- Interventions
Placebos for acetaminophen and N-acetylcysteine, APAP 1 gm every 6 hours and N-acetylcysteine placebo, NAC IV infusion at 0.5 gm hourly and APAP placebo, APAP 1 gm q6 hours, plus NAC IV infusion at 0.5 gm hourly, APAP 1.5 gm q6 hours, plus NAC IV infusion at 0.5 gm hourly
- First posted
- 2008-01-03
- Last updated
- 2025-04-18
- Results first posted
- 2025-04-18
- Limitations and caveats
The original trial had multiple stops and starts in enrollment due to PI relocation and funding gaps. This prolonged the patient enrollment periods. Further, the original PI unexpectedly passed away quite suddenly at which point the data management and supervision of the trial reporting passed to its current reporting physician.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Vasospasm Based on Magnetic Resonance Angiography (MRA) | 8 Days post subarachnoid hemorrhage (SAH) event | Presence of vasospasm measured Magnetic Resonance Angiography (MRA). MRA measures the degree of arterial narrowing, with a higher score indicating more severe vasospasm. An MRA score of 84% sensitivity and 72% specificity is indicative of vasospasm. |
| Primary | Number of Patients With Vasospasm Based on Computed Tomographic Angiography (CTA) | 8 Days post subarachnoid hemorrhage (SAH) event | Presence of vasospasm measured by Computed Tomographic Angiography (CTA). CTA scores range from 0 (no vasospasm) to 34, where a score of 10 or more is indicative of vasospasm. |
| Primary | National Institutes of Health Stroke Scale (NIHSS) Score | 8 Days post subarachnoid hemorrhage (SAH) event | The scale measures the severity of symptoms associated with patient's stroke. It assesses the severity of impairments related to stroke. The impairments are graded on a 3-4 point scale with scores that range from 0-42. Patients with a higher score have a more severe impairment, and patients with a lower score have a less severe impairment. |
| Primary | Modified Rankin Scale (MRS) Score | 8 Days post subarachnoid hemorrhage (SAH) event | The modified Rankin Scale (mRS) is used for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The 7 point ordinal scale ranges from No symptoms (0) to Death (6), with higher scores representing worse outcome. |
| Primary | Glasgow Outcome Scale (GOS) Score | 8 Days post subarachnoid hemorrhage (SAH) event | The Glasgow Outcome Scale (GOS) is a scale used to assess recovery of participants with brain damage. The scale has 5 categories: Death (1), Persistent vegetative state (2), Severe disability (3), Moderate disability (4), Good recovery (5). |
| Primary | The Barthel Index Score | 8 Days post subarachnoid hemorrhage (SAH) event | The Barthel index measures the extent to which someone can function independently during basic activities of daily living. Scores range from (from 0 to 100), 0 meaning disability and 100 meaning independence, therefore, higher score, better outcome. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Vasospasm Based on Magnetic Resonance Angiography (MRA) | 8 Days post subarachnoid hemorrhage (SAH) event | No data for the prespecified outcome was analyzed due to the NIH-approved SAP that is powered for 34 placebo subjects and 34 N-acetylcysteine subjects to be able to reject the null hypothesis that the failure rates for placebo and N-acetylcysteine subjects are equal with probability (power) 0.8. Only 44 participants were randomized. As such, no data analysis will be completed for this underpowered study. | ||
| PRIMARY | Number of Patients With Vasospasm Based on Computed Tomographic Angiography (CTA) | 8 Days post subarachnoid hemorrhage (SAH) event | No data for the prespecified outcome was analyzed due to the NIH-approved SAP that is powered for 34 placebo subjects and 34 N-acetylcysteine subjects to be able to reject the null hypothesis that the failure rates for placebo and N-acetylcysteine subjects are equal with probability (power) 0.8. Only 44 participants were randomized. As such, no data analysis will be completed for this underpowered study. | ||
| PRIMARY | National Institutes of Health Stroke Scale (NIHSS) Score | 8 Days post subarachnoid hemorrhage (SAH) event | No data for the prespecified outcome was analyzed due to the NIH-approved SAP that is powered for 34 placebo subjects and 34 N-acetylcysteine subjects to be able to reject the null hypothesis that the failure rates for placebo and N-acetylcysteine subjects are equal with probability (power) 0.8. Only 44 participants were randomized. As such, no data analysis will be completed for this underpowered study. | ||
| PRIMARY | Modified Rankin Scale (MRS) Score | 8 Days post subarachnoid hemorrhage (SAH) event | No data for the prespecified outcome was analyzed due to the NIH-approved SAP that is powered for 34 placebo subjects and 34 N-acetylcysteine subjects to be able to reject the null hypothesis that the failure rates for placebo and N-acetylcysteine subjects are equal with probability (power) 0.8. Only 44 participants were randomized. As such, no data analysis will be completed for this underpowered study. | ||
| PRIMARY | Glasgow Outcome Scale (GOS) Score | 8 Days post subarachnoid hemorrhage (SAH) event | No data for the prespecified outcome was analyzed due to the NIH-approved SAP that is powered for 34 placebo subjects and 34 N-acetylcysteine subjects to be able to reject the null hypothesis that the failure rates for placebo and N-acetylcysteine subjects are equal with probability (power) 0.8. Only 44 participants were randomized. As such, no data analysis will be completed for this underpowered study. | ||
| PRIMARY | The Barthel Index Score | 8 Days post subarachnoid hemorrhage (SAH) event | No data for the prespecified outcome was analyzed due to the NIH-approved SAP that is powered for 34 placebo subjects and 34 N-acetylcysteine subjects to be able to reject the null hypothesis that the failure rates for placebo and N-acetylcysteine subjects are equal with probability (power) 0.8. Only 44 participants were randomized. As such, no data analysis will be completed for this underpowered study. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | N-acetylcysteine IV Infusion at 0.5 gm Hourly | 16 | |
| Overall Study | STARTED | Placebo for N-acetylcysteine IV Infusion at 0.5 gm Hourly | 17 | |
| Overall Study | STARTED | Acetaminophen Plus N-acetylcysteine Infusion | 11 | |
| Overall Study | COMPLETED | N-acetylcysteine IV Infusion at 0.5 gm Hourly | 16 | |
| Overall Study | COMPLETED | Placebo for N-acetylcysteine IV Infusion at 0.5 gm Hourly | 17 | |
| Overall Study | COMPLETED | Acetaminophen Plus N-acetylcysteine Infusion | 11 | |
| Overall Study | NOT COMPLETED | N-acetylcysteine IV Infusion at 0.5 gm Hourly | 0 | |
| Overall Study | NOT COMPLETED | Placebo for N-acetylcysteine IV Infusion at 0.5 gm Hourly | 0 | |
| Overall Study | NOT COMPLETED | Acetaminophen Plus N-acetylcysteine Infusion | 0 |
Source ClinicalTrials.gov
Adverse events21
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Rash | Skin and subcutaneous tissue disorders | N-acetylcysteine IV Infusion at 0.5 gm Hourly | 1 | 16 | |
| other | Rash | Skin and subcutaneous tissue disorders | Placebo for N-acetylcysteine IV Infusion at 0.5 gm Hourly | 0 | 17 | |
| other | Rash | Skin and subcutaneous tissue disorders | Acetaminophen Plus N-acetylcysteine IV Infusion | 0 | 11 | |
| other | Diarrhea | Gastrointestinal disorders | N-acetylcysteine IV Infusion at 0.5 gm Hourly | 0 | 16 | |
| other | Diarrhea | Gastrointestinal disorders | Placebo for N-acetylcysteine IV Infusion at 0.5 gm Hourly | 1 | 17 | |
| other | Diarrhea | Gastrointestinal disorders | Acetaminophen Plus N-acetylcysteine IV Infusion | 0 | 11 | |
| other | Tachycardia | Cardiac disorders | N-acetylcysteine IV Infusion at 0.5 gm Hourly | 0 | 16 | |
| other | Tachycardia | Cardiac disorders | Placebo for N-acetylcysteine IV Infusion at 0.5 gm Hourly | 0 | 17 | |
| other | Tachycardia | Cardiac disorders | Acetaminophen Plus N-acetylcysteine IV Infusion | 1 | 11 | |
| serious | Vasospasm | Nervous system disorders | N-acetylcysteine IV Infusion at 0.5 gm Hourly | 0 | 16 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | N-acetylcysteine IV Infusion at 0.5 gm Hourly | 3 | 16 |
| Total, all-cause mortality | Placebo for N-acetylcysteine IV Infusion at 0.5 gm Hourly | 6 | 17 |
| Total, all-cause mortality | Acetaminophen Plus N-acetylcysteine IV Infusion | 0 | 11 |
| Total, other adverse events | N-acetylcysteine IV Infusion at 0.5 gm Hourly | 1 | 16 |
| Total, other adverse events | Placebo for N-acetylcysteine IV Infusion at 0.5 gm Hourly | 1 | 17 |
| Total, other adverse events | Acetaminophen Plus N-acetylcysteine IV Infusion | 1 | 11 |
| Total, serious adverse events | N-acetylcysteine IV Infusion at 0.5 gm Hourly | 1 | 16 |
| Total, serious adverse events | Placebo for N-acetylcysteine IV Infusion at 0.5 gm Hourly | 4 | 17 |
| Total, serious adverse events | Acetaminophen Plus N-acetylcysteine IV Infusion | 2 | 11 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P50GM015431 | Research Center for Pharmacology and Drug Toxicology | ROBERTS, II, L JACKSON | VANDERBILT UNIVERSITY | NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES | 1985 to 2010 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00585559
GET https://conductscience.org/api/trials/v1/NCT00585559/events?page=2