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| Sponsor: | State University of New York - Upstate Medical University |
|---|---|
| Information provided by: | State University of New York - Upstate Medical University |
| ClinicalTrials.gov Identifier: | NCT00617955 |
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: | Cohort, Retrospective |
| Official Title: | Systemic Effects of Aprotinin During Cardiac Surgery/ Long Term Death Rates |
| Enrollment: | 462 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 2013 (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
|
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 |
Cardiac Surgery patients
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, New York | |
| SUNY Upstate Medical University | |
| Syracuse, New York, United States, 13210 | |
| Principal Investigator: | Nancy A Nussmeier, MD | State University of New York - Upstate Medical University |
More Information
| Responsible Party: | SUNY Upstate Medical University, Dept. of Anesthesiology ( Nancy A. Nussmeier, MD ) |
| Study ID Numbers: | Aprotinin, IRB Exempt #10-06, IRB #5571, NDI Y7-X070 |
| Study First Received: | February 6, 2008 |
| Last Updated: | June 25, 2009 |
| ClinicalTrials.gov Identifier: | NCT00617955 History of Changes |
| Health Authority: | United States: Center for Disease Control; United States: Institutional Review Board |
|
Serine Proteinase Inhibitors Molecular Mechanisms of Pharmacological Action Coagulants Hematologic Agents Enzyme Inhibitors 6-Aminocaproic Acid Pharmacologic Actions |
Hemostatics Aprotinin Protease Inhibitors Fibrin Modulating Agents Antifibrinolytic Agents Therapeutic Uses Trypsin Inhibitors |
