NCT00617955

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, 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%.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
462

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 18, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

April 19, 2016

Status Verified

December 1, 2009

Enrollment Period

1.8 years

First QC Date

February 6, 2008

Last Update Submit

April 18, 2016

Conditions

Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

  • Long term death rates

    4 years

Study Arms (1)

Surgical

Cardiac surgery patients that received Aprotinin or Amicar

Drug: AprotininDrug: Amicar

Interventions

AprotininDRUG

compare outcomes of Aprotinin versus Amicar

Surgical
AmicarDRUG

compare outcomes of Aprotinin versus Amicar

Surgical

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Cardiac Surgery patients

You may qualify if:

  • Subjects must be 18 years of age or older
  • Subjects must have received either Aprotinin or Amicar during cardiac surgery

You may not qualify if:

  • Cardiac surgery and did not receive Aprotinin or Amicar

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

MeSH Terms

Interventions

AprotininAminocaproic Acid

Intervention Hierarchy (Ancestors)

ProteinsAmino Acids, Peptides, and ProteinsAminocaproatesCaproatesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino Acids

Study Officials

  • Nancy A Nussmeier, MD

    State University of New York - Upstate Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 6, 2008

First Posted

February 18, 2008

Study Start

September 1, 2007

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

April 19, 2016

Record last verified: 2009-12

Locations

US(1)