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NCT01420978 · ClinicalTrials.gov registry record · NA
Cerebrospinal Fluid (CSF) Drainage Study
A NA study, sponsored by Mayo Clinic.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT01420978: Completed NA study, sponsored by Mayo Clinic.
NCT01420978 is a NA study that has completed, run by Mayo Clinic. The registered enrollment target is 20 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01420978, a NA study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
When patients suffer a subarachnoid hemorrhage (bleeding around the brain), they often develop hydrocephalus. This is an enlargement of the fluid-filled spaces (ventricles) in the brain. Standard-of-care treatment includes placing an external ventricular drain (EVD) to drain off fluid. Eventually the EVD is weaned with the goal of removing it. Occasionally a patient does not tolerate this and a permanent surgery needs to be done to internalize a shunt. Though this is done commonly and routinely throughout the world, there are no good studies to address how to optimally set the EVD level and how fast to wean it. Most set the EVD to a level of around 15 mmHg. The investigators hypothesize that setting the EVD lower (which will allow higher volume Cerebrospinal Fluid (CSF) drainage through the EVD) will improve perfusion at the level of the microcirculation in the brain, and result in improved neurologic outcomes.
Primary Outcome
The primary outcome is clinical outcome at 90 days. A favorable outcome is defined as a score of 1 or 2 on the modified Rankin Score (mRS) and poor outcome defined as a mRS of 3-6. This assessment will be made by a clinician who was blinded to the patient's CSF diversion treatment arm.
Interventions
- PROCEDURE CSF Diversion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-08 |
| Est. Completion | 2013-02 |
| Phase | NA |
What the finished NCT01420978 record still lists
NCT01420978 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which CSF Diversion is the first listed.
NCT01420978 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01420978 about?
NCT01420978 is a clinical study titled "Cerebrospinal Fluid (CSF) Drainage Study". When patients suffer a subarachnoid hemorrhage (bleeding around the brain), they often develop hydrocephalus. This is an enlargement of the fluid-filled spaces (ventricles) in the brain. Standard-of-care treatment includes placing an external ventricular drain (EVD) to drain off fluid. Eventually th...
What is the current status of trial NCT01420978?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2011-08. Estimated completion is 2013-02.
What interventions are being tested in trial NCT01420978?
The interventions under investigation include: CSF Diversion (PROCEDURE).
Who is sponsoring clinical trial NCT01420978?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01420978's enrollment target sits among peer trials
20 1768th of 2000 higher than 140 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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