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Effects of Aprotinin During Cardiac Surgery/Long Term Death Rates

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00617955
Recruitment Status : Completed
First Posted : February 18, 2008
Last Update Posted : April 19, 2016
Information provided by:
State University of New York - Upstate Medical University

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, 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 or disease Intervention/treatment
Cardiac Surgery Drug: Aprotinin Drug: 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.

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Study Type : Observational
Actual Enrollment : 462 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Systemic Effects of Aprotinin During Cardiac Surgery/ Long Term Death Rates
Study Start Date : September 2007
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Group/Cohort Intervention/treatment
Cardiac surgery patients that received Aprotinin or Amicar
Drug: Aprotinin
compare outcomes of Aprotinin versus Amicar

Drug: Amicar
compare outcomes of Aprotinin versus Amicar

Primary Outcome Measures :
  1. Long term death rates [ Time Frame: 4 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Cardiac Surgery patients

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00617955

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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
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Principal Investigator: Nancy A Nussmeier, MD State University of New York - Upstate Medical University

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Responsible Party: Nancy A. Nussmeier, MD, SUNY Upstate Medical University, Dept. of Anesthesiology Identifier: NCT00617955    
Other Study ID Numbers: Aprotinin
IRB Exempt #10-06
IRB #5571
NDI Y7-X070
First Posted: February 18, 2008    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: December 2009
Additional relevant MeSH terms:
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Aminocaproic Acid
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifibrinolytic Agents
Fibrin Modulating Agents