Effects of Aprotinin During Cardiac Surgery/Long Term Death Rates

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%.

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Key information

Conditions

Cardiac Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aprotinin

Drug

compare outcomes of Aprotinin versus Amicar

Amicar

Drug

compare outcomes of Aprotinin versus Amicar

Primary outcomes

Long term death rates

Time frame: 4 years

Sponsors and collaborators

Lead sponsor

State University of New York - Upstate Medical University

Other

Registry information

Official study title

Systemic Effects of Aprotinin During Cardiac Surgery/ Long Term Death Rates

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Feb 18, 2008
Registry last updated: Apr 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed