Occurrence of Bleeding and Thrombosis During Antiplatelet Therapy in Non-cardiac Surgery (OBTAIN)
- 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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Occurrence of Bleeding and Thrombosis During Antiplatelet Therapy in Non-cardiac Surgery. A Prospective Observational Study (OBTAIN Study)|
- 1. MACE [ Time Frame: In-hospital stay up to 30 days ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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.
|Study Start Date:||October 2011|
|Study Completion Date:||January 2014|
|Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: 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|