- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00617955
Effects of Aprotinin During Cardiac Surgery/Long Term Death Rates
April 18, 2016 updated by: State University of New York - Upstate Medical University
Systemic 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%.
Study Overview
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 Type
Observational
Enrollment (Actual)
462
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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Syracuse, New York, United States, 13210
- SUNY Upstate Medical University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Cardiac Surgery patients
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Surgical
Cardiac surgery patients that received Aprotinin or Amicar
|
compare outcomes of Aprotinin versus Amicar
compare outcomes of Aprotinin versus Amicar
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Long term death rates
Time Frame: 4 years
|
4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Nancy A Nussmeier, MD, State University of New York - Upstate Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2007
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
February 6, 2008
First Submitted That Met QC Criteria
February 15, 2008
First Posted (Estimate)
February 18, 2008
Study Record Updates
Last Update Posted (Estimate)
April 19, 2016
Last Update Submitted That Met QC Criteria
April 18, 2016
Last Verified
December 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Aprotinin
- IRB Exempt #10-06
- IRB #5571
- NDI Y7-X070
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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