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Heparin Resistance: Predictors and Outcomes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01044888
First Posted: January 8, 2010
Last Update Posted: February 2, 2012
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.
Information provided by (Responsible Party):
Yonsei University
  Purpose
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 Intervention
Off Pump Coronary Artery Bypass Surgery Drug: Heparin

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Yonsei University:

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

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

Enrollment: 199
Study Start Date: April 2007
Study Completion Date: September 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
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.
  Eligibility

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

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.
  Contacts and Locations
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): NCT01044888


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

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01044888     History of Changes
Other Study ID Numbers: 4-2007-0142
First Submitted: January 7, 2010
First Posted: January 8, 2010
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:
Calcium heparin
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action