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Trial record 32 of 36 for:    AMINOCAPROIC ACID

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

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ClinicalTrials.gov Identifier: NCT00405093
Recruitment Status : Completed
First Posted : November 29, 2006
Last Update Posted : January 19, 2017
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief Summary:

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 or disease
Circulatory Arrest

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 1250 participants
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.
Study Start Date : July 2006
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Aprotinin





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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00405093


Locations
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United States, New York
The New York Presbyterian Hospital - Weill Medical College of Cornell University
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: James Osorio, MD Associate Professor

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00405093     History of Changes
Other Study ID Numbers: 0607008636
First Posted: November 29, 2006    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Weill Medical College of Cornell University:
cardiopulmonary bypass
circulatory arrest
aprotinin
thoracic aorta surgery
Additional relevant MeSH terms:
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Heart Arrest
Heart Diseases
Cardiovascular Diseases
Aprotinin
Hemostatics
Coagulants
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action