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Completed

NCT Number: NCT01044888

Heparin Resistance: Predictors and Outcomes

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.

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Key information

Conditions

Off Pump Coronary Artery Bypass Surgery Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yonsei University Severance hospital

Seoul, Seodaemungu, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Heparin

Drug

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 outcomes

  1. incidences of postoperative MI and major morbidity

    Time frame: immediate postoperative period

Secondary outcomes

  1. incidences of cardiac morbidities

    Time frame: 6 months following surgery

  2. restenosis of graft vessels

    Time frame: 6 months following surgery

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Official study title

Heparin Resistance During Off-pump Coronary Artery Bypass Graft Surgery: Predictors and Clinical Implication

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 8, 2010
Registry last updated
Feb 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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