Effects of Aprotinin During Cardiac Surgery/Long Term Death Rates
Information source: State University of New York - Upstate Medical University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiac Surgery
Intervention: Aprotinin (Drug); Amicar (Drug)
Status: Active, not recruiting
Sponsored by: State University of New York - Upstate Medical University
Official(s) and/or principal investigator(s):
Nancy A Nussmeier, MD, Principal Investigator, Affiliation: State University of New York - Upstate Medical University
The dept. of Anesthesiology currently has a database of subjects whom had surgery and
received either Aprotinin or Amicar in the OR. The current viewpoint is that Aprotinin is
more harmful than Amicard. In an effort to see what the long term outcomes were for subjects
whom had surgery here at Upstate, it was decided to look at long term death rates to see if
any differences. A student t-test will be used to determine statistical significance where a
p value of <0. 05 will be deemed significant. Using data from 462 subjects that had undergone
cardiac surgery at SUNY Upstate Medical University, CABG only and the long term mortality
rate from the Mangano, et. al. publications, the unadjusted mortality for the two drugs are
Aprotinin 5. 4% and Amicar 1. 2%. A power analysis was performed using the hospital mortality
rates of 5. 4% and 1. 2% with the sample size in the propensity data and a p-value of 0. 05.
The result was a power of 81. 7%.
Official title: Systemic Effects of Aprotinin During Cardiac Surgery/ Long Term Death Rates
Study design: Cohort, Retrospective
Primary outcome: Long term death rates
Charts for 462 subjects will be reviewed from 2002-2005 based on the surgery performed. From
each chart, the subject name, date of birth,and social security number will be recorded along
with the state of residence and year of surgery. This information will be transferred to a
CD that is encrypted and password protected. The CD will be sent via FedEx overnight to the
Center for Disease Control(CDC), National Death Registry. The CDC will use the information
on the CD to extract death outcomes for each subject's information provided. Once all
information is complete, the CDC will transfer on to a CD that is encrypted and password
protected and return to our office via FexEx overnight. The information on the CD will then
be used to determine what the long term death rates were for subjects here at SUNY Upstate
Medical University and stored in an anonymous database. Once the information is verified as
accurate, the CD will be destroyed and no identifying information will be kept. The CDC will
also destroy the information after 60 days, with no links to the identifying information.
Minimum age: 18 Years.
Maximum age: N/A.
- Subjects must be 18 years of age or older
- Subjects must have received either Aprotinin or Amicar during cardiac surgery
- Cardiac surgery and did not receive Aprotinin or Amicar
Locations and Contacts
SUNY Upstate Medical University, Syracuse, New York 13210, United States
Starting date: September 2007
Ending date: February 2013
Last updated: February 15, 2008