A Phase 4 interventional study of Gaymar Rapr-Round (external cooling blanket) in Fever and Brain Hemorrhage, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2013-05-06.
Sponsored by Northwestern University · Phase 4, Interventional, and Treatment
There are few treatments for central fever (fever that is due to the central nervous system, as opposed to an infectious source). We hypothesize that an externally applied cooling blanket will reduce temperature in neurologically ill patients with central fever.
199 studies on the registry are indexed under Intracranial Hemorrhages; 64 are open to participants now.
This study's enrollment of 20 is below the median of 100 across 105 interventional studies indexed under Intracranial Hemorrhages.
Browse Intracranial Hemorrhages studies →Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.
Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Application of the Gaymar Rapr-Round device per approved use
Device: Gaymar Rapr-Round (external cooling blanket)
Application of the device per its approved labeling
Core Temperature as Measured With an Approved Device (Urinary Catheter) in Place for Usual Clinical Care
Core temperature (in degrees Fahrenheit, F) throughout the study period. The cooling blanket was in place throughout the study period unless severe shivering led to termination per protocol.
Time frame: baseline, one, two and six hours after application.
Time From Start of Cooling Device to Core Temperature < 100.4F
For all patients, the time until the core temperature (measured with a urinary catheter in place for usual clinical care) was \<100.4F
Time frame: Six hours
Number of Participants With Severe Shivering
Severe shivering as measured by the bedside shivering assessment scale: 0 None: no shivering noted on palpation of the masseter, neck, or chest wall 1. Mild: shivering localized to the neck and/or thorax only 2. Moderate: shivering involves gross movement of the upper extremities (in addition to neck and thorax) 3. Severe: shivering involves gross movements of the trunk and upper and lower extremities
Time frame: six hours
Number of Participants With Hypotension
New systolic blood pressure \< 100 mm Hg, or new vasopressor use during study period
Time frame: six hours
Number of Participants With Arrhythmia
New ventricular tachycardia, ventricular fibrillation, atrial fibrillation or other unstable cardiac rhythm
Time frame: Six hours
| Milestone | Treatment Group |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
Core temperature (in degrees Fahrenheit, F) throughout the study period. The cooling blanket was in place throughout the study period unless severe shivering led to termination per protocol.
| degrees F | Treatment Group at 0, 1, 2, 6 Hours |
|---|---|
| 0 hours | 100.8 ± 0.4 |
| 1 hour | 100.3 ± 0.9 |
| 2 hours | 99.9 ± 1.1 |
| 6 hours | 99.5 ± 0.7 |
For all patients, the time until the core temperature (measured with a urinary catheter in place for usual clinical care) was \<100.4F
| hours | Treatment Group |
|---|---|
| Time From Start of Cooling Device to Core Temperature < 100.4F | 2.1 ± 1.6 |
Severe shivering as measured by the bedside shivering assessment scale: 0 None: no shivering noted on palpation of the masseter, neck, or chest wall 1. Mild: shivering localized to the neck and/or thorax only 2. Moderate: shivering involves gross movement of the upper extremities (in addition to neck and thorax) 3. Severe: shivering involves gross movements of the trunk and upper and lower extremities
| participants | Treatment Group |
|---|---|
| Number of Participants With Severe Shivering | 4 |
New systolic blood pressure \< 100 mm Hg, or new vasopressor use during study period
| participants | Treatment Group |
|---|---|
| Number of Participants With Hypotension | 0 |
New ventricular tachycardia, ventricular fibrillation, atrial fibrillation or other unstable cardiac rhythm
| participants | Treatment Group |
|---|---|
| Number of Participants With Arrhythmia | 0 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment Group | — | 4/20 (20%) | 0/20 (0%) |
| Event | Treatment Group |
|---|---|
| ShiveringNervous system disorders | 4/20 |
| Age Continuous(years) | Treatment Group |
|---|---|
| Mean | 54.3 ± 15.4 |
| Sex: Female, Male(Participants) | Treatment Group |
|---|---|
| Female | 7 |
| Male | 13 |
| Region of Enrollment(participants) | Treatment Group |
|---|---|
| United States | 20 |
This study is completed, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
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