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NCT01530880 · ClinicalTrials.gov registry record · Phase 4
Aggressive Fever Control With Intravenous Ibuprofen After Non-traumatic Brain Hemorrhage
A Phase 4 study, sponsored by Columbia University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 35
- Enrollment target
NCT01530880: Clinical Trial Phase 4 study, sponsored by Columbia University.
NCT01530880 is a Phase 4 study that was terminated before completion, run by Columbia University. The registered enrollment target is 35 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01530880, a Phase 4 study, was terminated before completion, sponsored by Columbia University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 35 participants
- Enrollment target
Study Summary
Fever, defined as temperature higher than 38.3C (100.9 F), is common in patients with head injuries and is associated with poor recovery after injury. The current standard of care is to use oral acetaminophen (Tylenol) followed by a body cooling device. This method can effectively reduce fever but results in a high rate of shivering. Shivering is stressful to the heart and can further worsen brain injury. Methods to combat shivering have been developed and are successful in limiting the stress in the majority of patients that use a body cooling device. However, the drugs used to control shivering are sedating and may also interfere with brain recovery. The purpose of this study is to assess whether ibuprofen given intravenously is more effective in combating fever than the current standard of care. Should results from this study demonstrate that ibuprofen infusion is effective, a larger study will be conducted to determine whether this aggressive fever control regimen leads to improved recovery after brain injury.
Primary Outcome
Reduction in fever burden (degrees C x hours) with intravenous ibuprofen infusion as compared to oral acetaminophen over duration of treatment. Fever burden is calculated hourly by subtracting each patient's recorded temperature (from either a bladder or esophageal temperature probe) from 37 degrees C.
Interventions
- DRUG Acetaminophen (Standard of Care)
- DRUG Intravenous Ibuprofen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2012-10 |
| Est. Completion | 2016-03-17 |
| Phase | Phase 4 |
Why NCT01530880 stopped before completion
NCT01530880 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Acetaminophen (Standard of Care) is the first listed.
NCT01530880 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01530880 about?
NCT01530880 is a clinical study titled "Aggressive Fever Control With Intravenous Ibuprofen After Non-traumatic Brain Hemorrhage". Fever, defined as temperature higher than 38.3C (100.9 F), is common in patients with head injuries and is associated with poor recovery after injury. The current standard of care is to use oral acetaminophen (Tylenol) followed by a body cooling device. This method can effectively reduce fever but r...
What is the current status of trial NCT01530880?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 35 participants. The study started on 2012-10. Estimated completion is 2016-03-17.
What interventions are being tested in trial NCT01530880?
The interventions under investigation include: Acetaminophen (Standard of Care) (DRUG), Intravenous Ibuprofen (DRUG).
Who is sponsoring clinical trial NCT01530880?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01530880's enrollment target sits among peer trials
35 1506th of 2000 higher than 481 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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