Heparin Resistance: Predictors and Outcomes
This study has been completed.
Information provided by (Responsible Party):
First received: January 7, 2010
Last updated: January 31, 2012
Last verified: January 2012
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.
Off Pump Coronary Artery Bypass Surgery
||Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
||Heparin Resistance During Off-pump Coronary Artery Bypass Graft Surgery: Predictors and Clinical Implication
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 ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2008 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years to 85 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- enrolling all consecutive patients scheduled for elective isolated multivessel OPCAB between April 2007 and March 2008
- presence of known preoperative coagulopathy, emergency operation or preoperative use of an intra-aortic balloon pump.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01044888
|Yonsei University Severance hospital
|Seoul, Seodaemungu, Korea, Republic of |
||Duk-Hee Chun, MD
||Yonsei University Severance Hospital
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 7, 2010
||January 31, 2012
||Korea: Institutional Review Board
Keywords provided by Yonsei University:
Off-pump coronary artery bypass graft surgery
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 01, 2015
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action