Effects of Aprotinin During Cardiac Surgery/Long Term Death Rates

This study has been completed.
Sponsor:
Information provided by:
State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT00617955
First received: February 6, 2008
Last updated: December 29, 2009
Last verified: December 2009
  Purpose

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%.


Condition Intervention
Cardiac Surgery
Drug: Aprotinin
Drug: Amicar

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Systemic Effects of Aprotinin During Cardiac Surgery/ Long Term Death Rates

Resource links provided by NLM:


Further study details as provided by State University of New York - Upstate Medical University:

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

Enrollment: 462
Study Start Date: September 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Surgical
Cardiac surgery patients that received Aprotinin or Amicar
Drug: Aprotinin
compare outcomes of Aprotinin versus Amicar
Drug: Amicar
compare outcomes of Aprotinin versus Amicar

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Cardiac Surgery patients

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00617955

Locations
United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Sponsors and Collaborators
State University of New York - Upstate Medical University
Investigators
Principal Investigator: Nancy A Nussmeier, MD State University of New York - Upstate Medical University
  More Information

No publications provided

Responsible Party: Nancy A. Nussmeier, MD, SUNY Upstate Medical University, Dept. of Anesthesiology
ClinicalTrials.gov Identifier: NCT00617955     History of Changes
Other Study ID Numbers: Aprotinin, IRB Exempt #10-06, IRB #5571, NDI Y7-X070
Study First Received: February 6, 2008
Last Updated: December 29, 2009
Health Authority: United States: Center for Disease Control
United States: Institutional Review Board

Additional relevant MeSH terms:
6-Aminocaproic Acid
Aprotinin
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 15, 2014