NCT00405093

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2006

Longer than P75 for all trials

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

July 1, 2006

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 29, 2006

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

January 19, 2017

Status Verified

January 1, 2017

Enrollment Period

6.8 years

First QC Date

November 28, 2006

Last Update Submit

January 17, 2017

Conditions

Circulatory Arrest

Keywords

cardiopulmonary bypasscirculatory arrestaprotininthoracic aorta surgery

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The New York Presbyterian Hospital - Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Study Officials

  • James Osorio, MD

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 28, 2006

First Posted

November 29, 2006

Study Start

July 1, 2006

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

January 19, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)