Effects of Aprotinin During Cardiac Surgery/Long Term Death Rates

NCT ID: NCT00617955

Last Updated: 2016-04-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 462 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2009-06-30

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.

Conditions

Cardiac Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Surgical

Cardiac surgery patients that received Aprotinin or Amicar

Aprotinin

Intervention Type: DRUG

compare outcomes of Aprotinin versus Amicar

Amicar

Intervention Type: DRUG

compare outcomes of Aprotinin versus Amicar

Interventions

Aprotinin

compare outcomes of Aprotinin versus Amicar

Intervention Type: DRUG

Amicar

compare outcomes of Aprotinin versus Amicar

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

State University of New York - Upstate Medical University

OTHER

Sponsor Role: lead

Responsible Party

SUNY Upstate Medical University, Dept. of Anesthesiology

Principal Investigators

Nancy A Nussmeier, MD

Role: PRINCIPAL_INVESTIGATOR

State University of New York - Upstate Medical University

Locations

SUNY Upstate Medical University

Syracuse, New York, United States

Countries

United States

Other Identifiers

IRB Exempt #10-06

Identifier Type: -

Identifier Source: secondary_id

IRB #5571

Identifier Type: -

Identifier Source: secondary_id

NDI Y7-X070

Identifier Type: -

Identifier Source: secondary_id

Aprotinin

Identifier Type: -

Identifier Source: org_study_id