Effects of Aprotinin During Cardiac Surgery/Long Term Death Rates

Status Completed

Clinical Trial 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%.

Clinical Trial 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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Cardiac Surgery

Clinical Trial Details

NCT number	NCT00617955
Study type	Observational
Source	State University of New York - Upstate Medical University
Contact
Status	Completed
Phase	N/A
Start date	September 2007
Completion date	June 2009

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05054179` - Pecto-Intercostal Fascial Plane Block Catheter Trial for Reduction of Sternal Pain	Phase 2/Phase 3
Completed	`NCT04051021` - Non-Pharmacological Interventions on Patient Experience and Healthcare Utilization in Adult Cardiac Surgery Patients	N/A
Recruiting	`NCT04604886` - The Consistency of Cardiac Output Measured by Pulmonary Artery Catheter and LiDCO in Cardiac Surgical Patients	N/A
Recruiting	`NCT04075981` - Prevention Atrial Fibrillation by BOTulinum Toxin Injections (BOTAF)	Phase 3
Completed	`NCT04062396` - Comparison of Remowell 2 and Inspire on Delirium and Cognitive Dysfunction	N/A
Recruiting	`NCT04709705` - DMSO Cryopreserved Platelets in Cardiopulmonary Bypass Surgery (CRYPTICS)	Phase 2/Phase 3
Not yet recruiting	`NCT05563662` - SURgical Registry of ENDocarditis EuRope
Withdrawn	`NCT03289104` - Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX	N/A
Completed	`NCT02964026` - Study of Clinical Outcomes Associated With the Pulmonary Artery Catheter (PAC) in Cardiac Surgery Patients	N/A
Completed	`NCT03563196` - Diagnosis Of Pulmonary Complications After Cardiac Surgery In Children
Completed	`NCT04199039` - Effects of Endotracheal Tube Fixation Methods on Hemodynamic Parameters During Endotracheal Suction	N/A
Completed	`NCT02471001` - The Levels of Anaesthetics in Heart Muscle During Heart Surgery	N/A
Completed	`NCT02325726` - RRI Compared With NephroCheckTM to Predict Acute Renal Failure After Cardiac Surgery.	N/A
Completed	`NCT01246947` - Tricuspid Annuloplasty for Moderate Tricuspid Regurgitation Associated With Miral Operation	N/A
Completed	`NCT01151254` - Comparison of Propofol Based Versus Volatile Based Anesthesia and Postoperative Sedation	N/A
Completed	`NCT00996099` - Continuous Glucose Monitoring Combined With Computer Algorithm for Intensive Insulin Therapy in Cardiosurgical Patients	N/A
Completed	`NCT00821262` - Sevoflurane in Cardiac Surgery	Phase 4
Completed	`NCT00336466` - The Erythropoietin NeuroProtective Effect: Assessment in CABG Surgery (TENPEAKS)	Phase 2
Completed	`NCT00337805` - Double Blind Randomized Trial of Saline vs Pentaspan for Resuscitation After Cardiac Surgery	Phase 2/Phase 3
Recruiting	`NCT04978636` - Low Tidal Volume Ventilation With Hyperoxia Avoidance During Cardiopulmonary Bypass (The FOCUS Trial)	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.