NCT01044888

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 8, 2010

Completed
Last Updated

February 2, 2012

Status Verified

January 1, 2012

Enrollment Period

11 months

First QC Date

January 7, 2010

Last Update Submit

January 31, 2012

Conditions

Off Pump Coronary Artery Bypass Surgery

Keywords

Heparin responsivenessOff-pump coronary artery bypass graft surgeryRisk factorsMyocardial infarction

Outcome Measures

Primary Outcomes (1)

  • incidences of postoperative MI and major morbidity

    immediate postoperative period

Secondary Outcomes (2)

  • incidences of cardiac morbidities

    6 months following surgery

  • restenosis of graft vessels

    6 months following surgery

Interventions

HeparinDRUG

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 Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • enrolling all consecutive patients scheduled for elective isolated multivessel OPCAB between April 2007 and March 2008

You may not qualify if:

  • presence of known preoperative coagulopathy, emergency operation or preoperative use of an intra-aortic balloon pump.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University Severance hospital

Seoul, Seodaemungu, South Korea

Location

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Heparin

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Duk-Hee Chun, MD

    Severance Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2010

First Posted

January 8, 2010

Study Start

April 1, 2007

Primary Completion

March 1, 2008

Study Completion

September 1, 2008

Last Updated

February 2, 2012

Record last verified: 2012-01

Locations

KR(1)