- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01044888
Heparin Resistance: Predictors and Outcomes
January 31, 2012 updated by: Yonsei University
Heparin Resistance During Off-pump Coronary Artery Bypass Graft Surgery: Predictors and Clinical Implication
The investigators evaluated clinical impact of reduced heparin responsiveness (HRreduced) on the incidence of perioperative myocardial infarction (MI) and restenosis at 6 months after off-pump coronary artery bypass graft surgery (OPCAB) and identified its predictors.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
199
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Seodaemungu
-
Seoul, Seodaemungu, Korea, Republic of
- Yonsei University Severance Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- enrolling all consecutive patients scheduled for elective isolated multivessel OPCAB between April 2007 and March 2008
Exclusion Criteria:
- presence of known preoperative coagulopathy, emergency operation or preoperative use of an intra-aortic balloon pump.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
incidences of postoperative MI and major morbidity
Time Frame: immediate postoperative period
|
immediate postoperative period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
incidences of cardiac morbidities
Time Frame: 6 months following surgery
|
6 months following surgery
|
restenosis of graft vessels
Time Frame: 6 months following surgery
|
6 months following surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Duk-Hee Chun, MD, Severance Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Primary Completion (Actual)
March 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
January 7, 2010
First Submitted That Met QC Criteria
January 7, 2010
First Posted (Estimate)
January 8, 2010
Study Record Updates
Last Update Posted (Estimate)
February 2, 2012
Last Update Submitted That Met QC Criteria
January 31, 2012
Last Verified
January 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2007-0142
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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