Effects of Aprotinin During Cardiac Surgery/Long Term Death Rates - Tabular View

Tracking Information

First Received Date ^ICMJE

February 6, 2008

Last Updated Date

June 25, 2009

Start Date ^ICMJE

September 2007

Estimated Primary Completion Date

February 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Long term death rates [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00617955 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Effects of Aprotinin During Cardiac Surgery/Long Term Death Rates

Official Title ^ICMJE

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

Brief 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%.

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.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Cohort, Retrospective

Condition ^ICMJE

Cardiac Surgery

Intervention ^ICMJE

Drug: Aprotinin
Drug: Amicar

Study Arms / Comparison Groups

Cardiac surgery patients that received Aprotinin or Amicar

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

462

Estimated Completion Date

February 2013

Estimated Primary Completion Date

February 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00617955

Responsible Party

Nancy A. Nussmeier, MD, SUNY Upstate Medical University, Dept. of Anesthesiology

Study ID Numbers ^ICMJE

Aprotinin, IRB Exempt #10-06, IRB #5571, NDI Y7-X070

Study Sponsor ^ICMJE

State University of New York - Upstate Medical University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Nancy A Nussmeier, MD

State University of New York - Upstate Medical University

Information Provided By

State University of New York - Upstate Medical University

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP