- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01358422
Occurrence of Bleeding and Thrombosis During Antiplatelet Therapy in Non-cardiac Surgery (OBTAIN)
October 12, 2015 updated by: European Society of Anaesthesiology
Occurrence of Bleeding and Thrombosis During Antiplatelet Therapy in Non-cardiac Surgery. A Prospective Observational Study (OBTAIN Study)
Research questions:
- What is the absolute risk reduction for in-hospital major adverse cardiac events (MACE) associated with the use of dual anti-platelet therapy as compared with aspirin alone in this population?
- What is the absolute risk increase for clinically significant bleeding during the same period associated with the use of dual anti-platelet therapy as compared with aspirin alone in this population?
In brief the design of the study is as follows:
- We will study patients undergoing non-cardiac surgery within four years of coronary stenting.
- We will record the anti-platelet agents taken by patients before, during and after surgery.
- We will record cardiac and bleeding events that occur whilst the patient is in hospital.
- We will use the statistical technique of propensity scoring to match patients who have similar risk factors and who received different anti-platelet regimens.
- We will compare the incidence of cardiac events and bleeding in the matched groups.
Study Overview
Status
Completed
Conditions
Detailed Description
This study will compare the use of aspirin alone with dual antiplatelet therapy (i.e.
aspirin and clopidogrel) in patients presenting for elective non-cardiac surgery who have undergone PCI with either bare metal stent or drug eluting stent placement in the four years prior to surgery.
The absolute risk reduction in major adverse cardiac events (MACE) with dual antiplatelet therapy and the absolute risk increase for clinically significant bleeding events with dual therapy will be determined.
This will allow the number needed to treat (NNT) for the prevention of MACE and the number needed to harm (NNH) for bleeding to be determined and the optimal antiplatelet therapy in this setting to be identified.
Study Type
Observational
Enrollment (Actual)
830
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Dresden, Germany, 01307
- University Hospital Carl Gustav Carus
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Rotterdam, Netherlands
- Erasmus University
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Leeds, United Kingdom, LS9 7TF
- University of Leeds, Sectional of Translational Anaesthetic and Surgical Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients undergoing non-cardiac surgery within four years of percutaneous coronary intervention (PCI) with the placement of a bare metal or drug eluting stent will be included in the study.
Description
Inclusion Criteria:
- Patients undergoing non-cardiac surgery within four years of percutaneous coronary intervention (PCI) with the placement of a bare metal or drug eluting stent will be included in the study.
Exclusion Criteria:
- Patients maintained on anticoagulant therapy e.g. heparin infusion before and after surgery will be excluded. (Patients receiving prophylactic doses of heparin for prevention of thromboembolic events will be eligible for inclusion.)
- Patients receiving bridging therapy with full anticoagulant does of heparin or other drugs to compensate for the withdrawal of antiplatelet drugs will be excluded.
- Patients who are anticoagulated with warfarin (INR>1.5 at the time of surgery) will be excluded.
- Patients receiving full anticoagulation with heparin for a known recent a known thromboembolic event (APPT ratio > 1.5) be excluded. -
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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In Patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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1. MACE
Time Frame: In-hospital stay up to 30 days
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This study will record and analyse in-hospital adverse cardiac events. Major Adverse Cardiac Events (MACE) will be defined as a composite of:
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In-hospital stay up to 30 days
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2. Clinically significant bleeding
Time Frame: In-hospital stay up to 30 days
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This study will record and analyse in-hospital clinically significant bleeding. Clinically Significant Bleeding Events will be defined as:
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In-hospital stay up to 30 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Simon Howell, MD, Sectional of Translational Anaesthetic and Surgical Sciences, University of Leeds, United Kingdom
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
May 20, 2011
First Submitted That Met QC Criteria
May 20, 2011
First Posted (Estimate)
May 23, 2011
Study Record Updates
Last Update Posted (Estimate)
October 14, 2015
Last Update Submitted That Met QC Criteria
October 12, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Keywords
- ESA
- non-cardiac surgery
- percutaneous coronary intervention (PCI)
- Prospective observational study
- European Society of Anaesthesiology
- major adverse cardiac events (MACE)
- clinically significant bleeding events
- Dual anti-platelet therapy
- aspirin alone therapy
- placement of a bare metal or drug eluting stent
- OBTAIN
- Simon Howell
Additional Relevant MeSH Terms
Other Study ID Numbers
- OBTAIN
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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