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Trial record 76 of 1000 for:    Heparin sodium

Heparin Resistance: Predictors and Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01044888
Recruitment Status : Completed
First Posted : January 8, 2010
Last Update Posted : February 2, 2012
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Off Pump Coronary Artery Bypass Surgery Drug: Heparin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Heparin Resistance During Off-pump Coronary Artery Bypass Graft Surgery: Predictors and Clinical Implication
Study Start Date : April 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Heparin
    150 U/kg heparin was administered intravenously at the beginning of graft anastomosis and accepted a perioperative ACT value of around 300 s. Ten minutes after the loading dose, the ACT was measured. An ACT of 300 s or greater was considered as adequate. Then follow up ACT measurement was determined after 30 min from the previous ACT measurement. If ACT fell below the target value of 300 s, an additional dose of heparin was administered. If ACT was between 250 and 299 s, additional 2000 U of heparin was administered and if ACT was between 200 and 249 s then additional 3000 U of heparin was injected. Ten minutes after additional heparin injection, ACT was remeasured.

Primary Outcome Measures :
  1. incidences of postoperative MI and major morbidity [ Time Frame: immediate postoperative period ]

Secondary Outcome Measures :
  1. incidences of cardiac morbidities [ Time Frame: 6 months following surgery ]
  2. restenosis of graft vessels [ Time Frame: 6 months following surgery ]

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT01044888

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Korea, Republic of
Yonsei University Severance hospital
Seoul, Seodaemungu, Korea, Republic of
Sponsors and Collaborators
Yonsei University
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Principal Investigator: Duk-Hee Chun, MD Severance Hospital

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Responsible Party: Yonsei University Identifier: NCT01044888     History of Changes
Other Study ID Numbers: 4-2007-0142
First Posted: January 8, 2010    Key Record Dates
Last Update Posted: February 2, 2012
Last Verified: January 2012

Keywords provided by Yonsei University:
Heparin responsiveness
Off-pump coronary artery bypass graft surgery
Risk factors
Myocardial infarction

Additional relevant MeSH terms:
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Calcium heparin
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action