Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 4 study that was terminated before completion, run by Columbia University. The registered enrollment target is 35 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01530880
The ClinicalTrials.gov registry entry for NCT01530880 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Columbia University, which has 958 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Acetaminophen (Standard of Care) is the first listed.
NCT01530880 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.