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NCT02064959 · ClinicalTrials.gov registry record · NA
To Study the Effect of Early Cooling in Acute Subdural Hematoma Patients
A NA study, sponsored by The University of Texas Health Science Center, Houston.
- Terminated
- Registry status
- NA
- Development phase
- 32
- Enrollment target
NCT02064959: Clinical Trial NA study, sponsored by The University of Texas Health Science Center, Houston.
NCT02064959 is a NA study that was terminated before completion, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 32 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02064959, a NA study, was terminated before completion, sponsored by The University of Texas Health Science Center, Houston.
- TERMINATED
- Registry status
- NA
- Development phase
- 32 participants
- Enrollment target
Study Summary
This randomized, prospective trial will study the effect of very early cooling in patients undergoing surgical evacuation of acute subdural hematomas (35°C prior to opening the dura followed by maintenance at 33°C for a minimum of 48h). Intravascular cooling catheters (Thermogard XP Device, Zoll) will be utilized to induce hypothermia or to maintain normothermia. The primary objective is to determine if rapid induction of hypothermia prior to emergent craniotomy for traumatic subdural hematoma (SDH) will improve outcome as measured by Glasgow Outcome Scale-Extended (GOSE) at 6 months.
Primary Outcome
Participants were monitored for 6 months after injury, and GOS-E was scored as favorable (moderate disability to good recovery) or unfavorable (severe disability, vegetative state, or death) at 6 months post-injury.
Interventions
- DEVICE Temperature management Zoll Intravascular Temperature Management device
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2014-03-22 |
| Est. Completion | 2019-02-07 |
| Phase | NA |
Why NCT02064959 stopped before completion
NCT02064959 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Temperature management Zoll Intravascular Temperature Management device is the first listed.
NCT02064959 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02064959 about?
NCT02064959 is a clinical study titled "To Study the Effect of Early Cooling in Acute Subdural Hematoma Patients". This randomized, prospective trial will study the effect of very early cooling in patients undergoing surgical evacuation of acute subdural hematomas (35°C prior to opening the dura followed by maintenance at 33°C for a minimum of 48h). Intravascular cooling catheters (Thermogard XP Device, Zoll) wi...
What is the current status of trial NCT02064959?
This trial is currently terminated. It is a NA study. The enrollment target is 32 participants. The study started on 2014-03-22. Estimated completion is 2019-02-07.
What interventions are being tested in trial NCT02064959?
The interventions under investigation include: Temperature management Zoll Intravascular Temperature Management device (DEVICE).
Who is sponsoring clinical trial NCT02064959?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02064959's enrollment target sits among peer trials
32 1578th of 2000 higher than 409 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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