Bleeding Clinical Trial
— OBTAINOfficial title:
Occurrence of Bleeding and Thrombosis During Antiplatelet Therapy in Non-cardiac Surgery. A Prospective Observational Study (OBTAIN Study)
Research questions:
1. 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?
2. 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.
Status | Completed |
Enrollment | 830 |
Est. completion date | January 2014 |
Est. primary completion date | December 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. - |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Carl Gustav Carus | Dresden | |
Netherlands | Erasmus University | Rotterdam | |
United Kingdom | University of Leeds, Sectional of Translational Anaesthetic and Surgical Sciences | Leeds |
Lead Sponsor | Collaborator |
---|---|
European Society of Anaesthesiology | Erasmus Medical Center, University of Leeds |
Germany, Netherlands, United Kingdom,
Howell SJ, Hoeks SE, Poldermans D, West RM, Wheatcroft SB. OBTAIN: a study of the occurrence of bleeding and thrombosis during anti-platelet therapy in non-cardiac surgery. Eur J Anaesthesiol. 2011 Jun;28(6):456-9. doi: 10.1097/EJA.0b013e328344b4fc. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 1. MACE | 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. |
In-hospital stay up to 30 days | No |
Primary | 2. Clinically significant bleeding | 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. |
In-hospital stay up to 30 days | No |
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