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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

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Mortality Study

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Study Status Completed
522 Number / Requirement Number PS040001 / PSS001
Date Current Plan Accepted 04/29/2005
Study Name Mortality Study
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 Design Description This study was designed as a cohort study using registry data collected from study hospitals

Study Population Description 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.

Data Collection 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

Mortality Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
October 2009 quarterly report 10/27/2009 10/27/2009 On Time
2nd extn req for final report 05/26/2010 05/26/2010 On Time
5-year report (final report) 06/12/2010 06/14/2010 On Time

  • The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance (PS) studies are conducted effectively and efficiently and in the least burdensome manner.
  • In May 2008, the oversight responsibility of the 522 Postmarket Surveillance Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH). DEPI continues to build the 522 program.
  • CDRH has established an automated internal tracking system that efficiently identifies the reporting status of active 522 PS studies based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all 522 PS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each 522 PS study. The webpage displays general information regarding each study, as well as the overall study status (based on protocol-driven timelines and adequacy of the data) and the applicant's reporting status for each submission due.


Contact Information

Cheryl Reynolds
Project Manager, 522 Postmarket Surveillance (PS) Studies Program
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-0002

Phone: (301) 796-6068
Fax: (301) 847-8140