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Heparin Resistance: Predictors and Outcomes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01044888
First received: January 7, 2010
Last updated: January 31, 2012
Last verified: January 2012
History of Changes
  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 Blind (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:

Drug Information available for: Heparin
U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • incidences of postoperative MI and major morbidity [ Time Frame: immediate postoperative period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • incidences of cardiac morbidities [ Time Frame: 6 months following surgery ] [ Designated as safety issue: No ]
  • restenosis of graft vessels [ Time Frame: 6 months following surgery ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Yonsei University Severance Hospital
  More Information

No publications provided

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01044888     History of Changes
Other Study ID Numbers: 4-2007-0142
Study First Received: January 7, 2010
Last Updated: January 31, 2012
Health Authority: Korea: Institutional Review Board

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
Hematologic Agents
Therapeutic Uses
 Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 18, 2013