Effects of Aprotinin During Cardiac Surgery/Long Term Death Rates

Completed

Conditions studied: Cardiac Surgery

In brief

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%.

Key facts

Study ID

NCT00617955

Run by

State University of New York - Upstate Medical University

People needed

462

Starts

2007-09-01

Expected to finish

2009-06-01

Last updated by the study team

2016-04-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must be 18 years of age or older
• Subjects must have received either Aprotinin or Amicar during cardiac surgery

You may not qualify if…

• Cardiac surgery and did not receive Aprotinin or Amicar

Where it is running

• SUNY Upstate Medical University — Syracuse, New York, United States

Full record on ClinicalTrials.gov

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