A Phase 1 interventional study of Zoll- Coolgaurd 3000 in Stroke, Acute, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2014-08-01.
Sponsored by Emory University · Phase 1, Interventional, and Treatment
The purpose of this study is to determine whether reducing a patients body temperature (mild hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury (notably reperfusion injury and hemorrhagic conversion) in patients that have suffered a significant interruption of blood flow to an area of brain (occlusion of large proximal cerebral artery) and have undergone successful removal of that interruption (revascularization).
7,443 studies on the registry are indexed under Stroke; 2,012 are open to participants now.
This study's enrollment of 20 is below the median of 50 across 5,482 interventional studies indexed under Stroke.
Browse Stroke studies →Emory University is the lead sponsor of 1,405 studies on the registry; 233 are open to participants now.
Of its 233 completed or terminated interventional studies of FDA-regulated products, 176 (76%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Reduction of body temperature to 34 degrees centigrade. This will be accomplished using the Zoll Coolguard .
Device: Zoll- Coolgaurd 3000
Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour.
Number of Participants With Reperfusion Injury \ Hemorrhagic Transformation
Asymptomatic and symptomatic Hemorrhages defined as homogenous density occupying \>30% of the infarct zone with mass effect
Time frame: 24 Hours
Modified Rankin Scale 0-2
Modified Rankin Score 0=no symptoms 1. no significant disability 2. slight disability needs help 3. moderate disability 4. moderate serve disability 5. severe disability 0-2 = good outcome 3-5= poor outcome
Time frame: 90 days post hospitalization
| Milestone | Mild Hypothermia |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
Asymptomatic and symptomatic Hemorrhages defined as homogenous density occupying \>30% of the infarct zone with mass effect
| participants | Mild Hypothermia |
|---|---|
| Number of Participants With Reperfusion Injury \ Hemorrhagic Transformation | 3 |
Modified Rankin Score 0=no symptoms 1. no significant disability 2. slight disability needs help 3. moderate disability 4. moderate serve disability 5. severe disability 0-2 = good outcome 3-5= poor outcome
| participants Modified Rankin Scal 0-2 | Mild Hypothermia |
|---|---|
| Modified Rankin Scale 0-2 | 20 |
Collected over 90 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mild Hypothermia | — | 8/20 (40%) | 0/20 (0%) |
| Event | Mild Hypothermia |
|---|---|
| PneumoniaInfections and infestations | 5/20 |
| Urinary Tract InfectionInfections and infestations | 4/20 |
| BacteremiaInfections and infestations | 1/20 |
| Deep Venous ThrombosisBlood and lymphatic system disorders | 1/20 |
| Age, Continuous(years) | Mild Hypothermia |
|---|---|
| Mean | 59 ± 14 |
| Sex: Female, Male(Participants) | Mild Hypothermia |
|---|---|
| Female | 8 |
| Male | 12 |
| Region of Enrollment(participants) | Mild Hypothermia |
|---|---|
| United States | 20 |
The record gives a start of May 2012, a primary completion of Aug 2012 and a completion of Aug 2012. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2014, 2 years after primary completion.
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This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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