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

This study is currently recruiting participants.

Verified by Weill Medical College of Cornell University, May 2009

First Received: November 28, 2006 Last Updated: May 27, 2009 History of Changes

Sponsored by:	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:	Case-Only, 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: Hypothermia Surgery

Drug Information available for: Aprotinin

U.S. FDA Resources

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

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	1000
Study Start Date:	July 2006
Estimated Study Completion Date:	July 2010

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:	Weill Cornell Medical College ( Manuel Fontes, MD )
Study ID Numbers:	0607008636
Study First Received:	November 28, 2006
Last Updated:	May 27, 2009
ClinicalTrials.gov Identifier:	NCT00405093 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:

cardiopulmonary bypass
circulatory arrest
aprotinin
thoracic aorta surgery

Study placed in the following topic categories:

Serine Proteinase Inhibitors
Hypothermia
Serine

Hemostatics
Protease Inhibitors
Aprotinin

Additional relevant MeSH terms:

Serine Proteinase Inhibitors
Coagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents
Trypsin Inhibitors

Enzyme Inhibitors
Hemostatics
Pharmacologic Actions
Protease Inhibitors
Aprotinin

ClinicalTrials.gov processed this record on July 02, 2009