Aprotinin Use and Renal Outcome in Hypothermic Bypass and Circulatory Arrest for Surgical Repair of Thoracic Aorta.

This study is currently recruiting participants.

Verified September 2010 by Weill Medical College of Cornell University

First Received on November 28, 2006. Last Updated on September 21, 2010 History of Changes

Sponsor:	Weill Medical College of Cornell University
Information provided by:	Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:	NCT00405093

Purpose

Primary Objective: The aim of this study is to assess the effects of Aprotinin (an antifibrinolytic drug used to reduce bleeding during cardiac surgery) on renal function in patients undergoing surgery with use of hypothermic bypass and circulatory arrest for repair of the thoracic aorta.

Secondary Objective: To compare the effects of Aprotinin and Amicar on major vascular outcomes following thoracic aorta surgery with use of hypothermic bypass and circulatory arrest.

Condition
Circulatory Arrest

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Retrospective
Official Title:	Aprotinin Use and Renal Outcome in Hypothermic Bypass and Circulatory Arrest for Surgical Repair of Thoracic Aorta. A Retrospective Study.

Resource links provided by NLM:

MedlinePlus related topics: Cardiac Arrest Hypothermia

Drug Information available for: Aprotinin

U.S. FDA Resources

Further study details as provided by Weill Medical College of Cornell University:

Estimated Enrollment:	1000
Study Start Date:	July 2006
Estimated Study Completion Date:	September 2011

Show Detailed Description

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Adult male and female patients having surgery of ascending and aortic arch with the use of Antifibrinolytic agents (Aprotinin and Aminocaproic Acid)

Criteria

Inclusion Criteria:

Adult male and female patients having surgery of ascending and aortic arch
Use of Antifibrinolytic agents (Aprotinin and Aminocaproic Acid)

Exclusion Criteria:

Emergency surgery for ruptured aorta
Pre-Existing Renal Failure or Renal dysfunction (creatinine >2.0 mg/dl)
Moderate or Severe Ventricular Dysfunction

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405093

Contacts

Contact: Manuel Fontes, MD

212-746-0395

maf2029@med.cornell.edu

Locations

United States, New York
The New York Presbyterian Hospital - Weill Medical College of Cornell University	Recruiting
New York, New York, United States, 10021
Contact: Manuel Fontes, MD 212-746-0395 maf2029@med.cornell.edu
Principal Investigator: Manuel Fontes, MD

Sponsors and Collaborators

Weill Medical College of Cornell University

Investigators

Principal Investigator:

Manuel Fontes, MD

Associate Professor

More Information

No publications provided

Responsible Party:	Manuel Fontes, MD, Weill Cornell Medical College
ClinicalTrials.gov Identifier:	NCT00405093 History of Changes
Other Study ID Numbers:	0607008636
Study First Received:	November 28, 2006
Last Updated:	September 21, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:

cardiopulmonary bypass
circulatory arrest
aprotinin
thoracic aorta surgery

Additional relevant MeSH terms:

Heart Arrest
Hypothermia
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes
Signs and Symptoms
Aprotinin
Trypsin Inhibitors
Serine Proteinase Inhibitors

Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012