Off Pump Coronary Artery Bypass SurgeryNCT01044888
Heparin Resistance: Predictors and Outcomes
A study testing Heparin in people with Off Pump Coronary Artery Bypass Surgery, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Off Pump Coronary Artery Bypass Surgery
- What is being tested?
- Heparin
- Type of treatment
- Injection or infusion
- How many people
- 199 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2007to Sep 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- enrolling all consecutive patients scheduled for elective isolated multivessel OPCAB between April 2007 and March 2008
Who cannot join
- presence of known preoperative coagulopathy, emergency operation or preoperative use of an intra-aortic balloon pump.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heparin Resistance During Off-pump Coronary Artery Bypass Graft Surgery: Predictors and Clinical Implication
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.
- Conditions
- Off Pump Coronary Artery Bypass Surgery
- Being tested
- Heparin
- Keywords
- Heparin responsiveness, Off-pump coronary artery bypass graft surgery, Risk factors, Myocardial infarction
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
incidences of postoperative MI and major morbidity
Measured: immediate postoperative period
Secondary outcomes (2)
incidences of cardiac morbidities
Measured: 6 months following surgery
restenosis of graft vessels
Measured: 6 months following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2010 (estimated)
- Study startApr 2007
- Primary completionMar 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Off Pump Coronary Artery Bypass SurgeryStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Duk-Hee Chun, MD, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044888
- Sponsor's protocol ID
- 4-2007-0142
- Status last verified
- Jan 2012
- First submitted
- 7 Jan 2010
- Last updated
- 2 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heparin Resistance During Off-pump Coronary Artery Bypass Graft Surgery: Predictors and Clinical Implication
- ClinicalTrials.gov ID
- NCT01044888
- Acronym / sponsor ID
- 4-2007-0142
- Conditions
- Off Pump Coronary Artery Bypass Surgery
- Keywords
- Heparin responsiveness, Off-pump coronary artery bypass graft surgery, Risk factors, Myocardial infarction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 8 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- enrolling all consecutive patients scheduled for elective isolated multivessel OPCAB between April 2007 and March 2008
Key exclusion criteria (1 listed)
- presence of known preoperative coagulopathy, emergency operation or preoperative use of an intra-aortic balloon pump.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heparin150 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. | Drug | – |
Primary outcome
incidences of postoperative MI and major morbidity
Time frame: immediate postoperative period
2 secondary outcomes
incidences of cardiac morbidities
Time frame: 6 months following surgery
restenosis of graft vessels
Time frame: 6 months following surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duk-Hee Chun, MD principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heparin in people with Off Pump Coronary Artery Bypass Surgery, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidences of postoperative MI and major morbidity (time frame: immediate postoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2012.