Coronary DiseaseHEMOCORNCT00825981
Primary and Secondary Hemostasis in Elective Coronary Artery Bypass Graft Surgery
An observational study of Coronary Disease, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Patients undergoing elective coronary artery bypass graft surgery (CABG) are treated with platelet inhibitors to reduce myocardial infarction and mortality.However, this can increase perioperative bleeding. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Disease
- What is being tested?
- screening coagulation abnormalities
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2009to Mar 2010
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: coronary artery bypass graft
Who may be able to join
- coronary artery bypass graft surgery with or without cardiopulmonary bypass
Who cannot join
- emergency; redo cardiac surgery; combined cardiac surgery; patients with renal insufficiency; patients with acquired coagulation abnormalities
Trial locations and contacts
1 site in 1 country.
Belgium1 site
Cliniques Universitaires Saint Luc
Brussels, Brussels Capital, 1200
About this study
Patients undergoing elective coronary artery bypass graft surgery (CABG) are treated with platelet inhibitors to reduce myocardial infarction and mortality.However, this can increase perioperative bleeding. A retrospective analysis of the data in our institution has revealed a significant increase in transfusion requirements after elective CABG since 5 years. The aim of our study is to observe if this increase in transfusion requirements is due to platelet inhibitors or due to other coagulation abnormalities resulting from other anticoagulants.
- Conditions
- Coronary Disease
- Being tested
- screening coagulation abnormalities
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
screening coagulation abnormalitiesOther
if specific coagulation abnormalities are observed which increase patient's risk of bleeding, appropriate treatment will start
| Study group | Role | What they receive |
|---|---|---|
| coronary artery bypass graft | patients undergoing elective coronary artery bypass graft with or without cardiopulmonary bypass Receives: Other: screening coagulation abnormalities |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825981
- Sponsor's protocol ID
- 2008/10DEC/350
- Acronym
- HEMOCOR
- Status last verified
- Jul 2010
- First submitted
- 16 Jan 2009
- Last updated
- 23 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Hertfelder HJ, Bos M, Weber D, Winkler K, Hanfland P, Preusse CJ. Perioperative monitoring of primary and secondary hemostasis in coronary artery bypass grafting. Semin Thromb Hemost. 2005;31(4):426-40. doi: 10.1055/s-2005-916678.
PubMed 16149021
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary and Secondary Hemostasis in Elective Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT00825981
- Acronym / sponsor ID
- HEMOCOR / 2008/10DEC/350
- Conditions
- Coronary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 21 Jan 2009 (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.
Patients undergoing elective coronary artery bypass graft surgery (CABG) are treated with platelet inhibitors to reduce myocardial infarction and mortality.However, this can increase perioperative bleeding. A retrospective analysis of the data in our institution has revealed a significant increase in transfusion requirements after elective CABG since 5 years. The aim of our study is to observe if this increase in transfusion requirements is due to platelet inhibitors or due to other coagulation abnormalities resulting from other anticoagulants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| coronary artery bypass graft | – | Other: screening coagulation abnormalitiespatients undergoing elective coronary artery bypass graft with or without cardiopulmonary bypass |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- coronary artery bypass graft
Key inclusion criteria (1 listed)
- coronary artery bypass graft surgery with or without cardiopulmonary bypass
Key exclusion criteria (1 listed)
- emergency; redo cardiac surgery; combined cardiac surgery; patients with renal insufficiency; patients with acquired coagulation abnormalities
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 |
|---|---|---|
| screening coagulation abnormalitiesif specific coagulation abnormalities are observed which increase patient's risk of bleeding, appropriate treatment will start | Other | coronary artery bypass graft |
Primary outcome
Not reported in the source record.
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 23 Jul 2010.
- Background: PubMed 16149021Hertfelder HJ, Bos M, Weber D, Winkler K, Hanfland P, Preusse CJ. Perioperative monitoring of primary and secondary hemostasis in coronary artery bypass grafting. Semin Thromb Hemost. 2005;31(4):426-40. doi: 10.1055/s-2005-916678.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Disease, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 23 Jul 2010. 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 Belgium. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00825981, which also lists 1 linked publication.
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 23 Jul 2010.