Occurrence of Bleeding and Thrombosis During Antiplatelet Therapy in Non-cardiac Surgery (OBTAIN)
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|ClinicalTrials.gov Identifier: NCT01358422|
Recruitment Status : Completed
First Posted : May 23, 2011
Last Update Posted : October 14, 2015
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- 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.
|Condition or disease|
|Bleeding Thrombosis Cardiac Events|
|Study Type :||Observational|
|Actual Enrollment :||830 participants|
|Official Title:||Occurrence of Bleeding and Thrombosis During Antiplatelet Therapy in Non-cardiac Surgery. A Prospective Observational Study (OBTAIN Study)|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||January 2014|
- 1. MACE [ Time Frame: In-hospital stay up to 30 days ]
This study will record and analyse in-hospital adverse cardiac events. Major Adverse Cardiac Events (MACE) will be defined as a composite of:
- Myocardial infarction as defined by the Universal Definition of Myocardial Infarction(including cardiac arrest and cardiac death as described in this definition).
- PCI for a cardiac event occurring following surgery.
- 2. Clinically significant bleeding [ Time Frame: In-hospital stay up to 30 days ]
This study will record and analyse in-hospital clinically significant bleeding.
Clinically Significant Bleeding Events will be defined as:
- Reoperation for bleeding.
- Gastrointestinal haemorrhage
- Intracranial haemorrhage
- Spinal/epidural haematoma. The transfusion of blood and blood products will also be recorded and compared between patients on dual antiplatelet therapy and aspirin alone.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
- 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.
- 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. -
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01358422
|University Hospital Carl Gustav Carus|
|Dresden, Germany, 01307|
|University of Leeds, Sectional of Translational Anaesthetic and Surgical Sciences|
|Leeds, United Kingdom, LS9 7TF|
|Study Chair:||Simon Howell, MD||Sectional of Translational Anaesthetic and Surgical Sciences, University of Leeds, United Kingdom|
|Responsible Party:||European Society of Anaesthesiology|
|Other Study ID Numbers:||
|First Posted:||May 23, 2011 Key Record Dates|
|Last Update Posted:||October 14, 2015|
|Last Verified:||October 2015|
Prospective observational study
major adverse cardiac events (MACE)
clinically significant bleeding events
Dual anti-platelet therapy
aspirin alone therapy
percutaneous coronary intervention (PCI)
placement of a bare metal or drug eluting stent
European Society of Anaesthesiology
Embolism and Thrombosis