MedTrace Logo

Effects of Aprotinin During Cardiac Surgery/Long Term Death Rates

NCT00617955 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 462

Last updated 2016-04-19

No results posted yet for this study

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%.

Conditions

  • Cardiac Surgery

Interventions

DRUG

Aprotinin

compare outcomes of Aprotinin versus Amicar

DRUG

Amicar

compare outcomes of Aprotinin versus Amicar

Sponsors & Collaborators

  • State University of New York - Upstate Medical University

    lead OTHER

Principal Investigators

  • Nancy A Nussmeier, MD · State University of New York - Upstate Medical University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00617955 on ClinicalTrials.gov