|
|
| General |
| Study Status |
Completed |
| 522 Number / Requirement Number |
PS040001 / PSS001 |
| Date Original Plan Accepted |
04/29/2005
|
| Date Current Plan Accepted |
04/29/2005
|
| Study Name |
Mortality Study
|
| Device Name |
Alsius coolgard 3000/coolline catheter thermal regulation system
|
| Root Document Number |
K014241
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adolescent: 13-18 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This study was designed as a cohort study using registry data collected from study hospitals
|
| Study Population |
The device cohort consisted of all patients treated with the Alsius CoolGard® 3000 and Cool LineTM Catheter Thermal Regulation system. The control cohort consisted of cerebral infarction (CI) and intracerebral hemorrhage (ICH) patients entering the Neurological intensive care units (ICUs) at the participating institutions before the first use of CoolGard under Postmarket Surveillance.
|
| Sample Size |
Two hundred patient records were reviewed for each cohort (i.e., 400 patients in total) from 9 hospitals.
|
| Key Study Endpoints |
The primary endpoint was 30-day or discharge mortality, which ever occurred first. The length of stay in the participating institutions was calculated and analyzed as a secondary endpoint
|
| Follow-up Visits and Length of Follow-up |
Subjects were followed through 30 days from enrollment or hospital discharge, whichever came first
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
584
|
| Actual Number of Sites Enrolled |
7
|
| Patient Followup Rate |
100%
|
| Final Safety Findings |
The observed 30-day mortality was 32.5% among the 209 patients enrolled in the Control Cohort and 34.6% among the 208 patients enrolled in the Device Cohort. The Device Cohort mortality was 2.1% higher than in the Control Cohort (90% CI: -0.055, 0.097). The upper limit of the 90% confidence interval was less than 0.10. The odds ratio for the 30-day mortality result was 1.10 (90% CI: 0.78, 1.54). The Device Cohort mortality in the low Glasgow Coma Scale (GCS) sub-group was 0.9% less than in the Control Cohort (90% CI: -0.113, 0.095), compared with 13.7% higher (90% CI: -0.051, 0.325) in the medium GCS patients, and 0.8% higher (90% CI: -0.146, 0.163) in the high GCS patients. The multivariable logistic regression analysis showed the estimated odds ratio for the comparison of mortality in the Device Cohort versus the Control Cohort was 1.48 (90% CI: 1.0, 2.18), adjusting for age, gender, GCS at baseline, and indications. With the observed 33% mortality rate in the control group and a 10% non-inferiority margin, the upper limit of the confidence interval for the odds ratio would have to be less than 1.53 for non-inferiority to hold. The upper bound of 2.18 well exceeded the 1.53 limit. The use of Alsius CoolGard 3000/CoolLine catheter thermal regulation system for fever reduction in CI and ICH patients does not appear to be associated with improved outcome in terms of mortality and length of hospital stay at 30 days
|
| Final Effectiveness Findings |
N/A Study based on saftey endpoint only
|
| Study Strengths and Weaknesses |
Detailed time variables and co-morbidities were not tracked. The secondary endpoint of hospital stay could not be accurately estimated. In addition, lack of clear time to event data has created the difficulty in interpreting the results, including mortality estimates
|
| Recommendations for Labeling Changes |
None
|
