Effects of Aprotinin During Cardiac Surgery/Long Term Death Rates
Information source: State University of New York - Upstate Medical University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cardiac Surgery
Intervention: Aprotinin (Drug); Amicar (Drug)
Phase: N/A
Status: Completed
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
Summary
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%.
Clinical Details
Official title: Systemic Effects of Aprotinin During Cardiac Surgery/ Long Term Death Rates
Study design: Observational Model: Cohort, Time Perspective: Retrospective
Primary outcome: Long term death rates
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects must be 18 years of age or older
- Subjects must have received either Aprotinin or Amicar during cardiac surgery
Exclusion Criteria:
- Cardiac surgery and did not receive Aprotinin or Amicar
Locations and Contacts
SUNY Upstate Medical University, Syracuse, New York 13210, United States
Additional Information
Starting date: September 2007
Last updated: December 29, 2009
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