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Occurrence of Bleeding and Thrombosis During Antiplatelet Therapy in Non-cardiac Surgery (OBTAIN)

This study is currently recruiting participants.
Verified February 2012 by European Society of Anaesthesiology
Sponsor:
Collaborators:
University of Leeds
Erasmus Medical Center
Information provided by (Responsible Party):
European Society of Anaesthesiology
ClinicalTrials.gov Identifier:
NCT01358422
First received: May 20, 2011
Last updated: February 20, 2012
Last verified: February 2012
History of Changes
  Purpose

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.

Condition
Bleeding
Thrombosis
Cardiac Events

Study Type: Observational
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)

Further study details as provided by European Society of Anaesthesiology:

Primary Outcome Measures:
  • 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:

    1. Myocardial infarction as defined by the Universal Definition of Myocardial Infarction(including cardiac arrest and cardiac death as described in this definition).
    2. 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:

    1. Reoperation for bleeding.
    2. Gastrointestinal haemorrhage
    3. Intracranial haemorrhage
    4. 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.


Estimated Enrollment: 1400
Study Start Date: October 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
In Patients

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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. -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01358422

Contacts
Contact: Sandrine Damster, Research Dpt +32-2-743-3294 sandrine@euroanaesthesia.com
Contact: Brigitte Leva, Research Dpt +322 210-9414 brigitte@euroanaesthesia.com

Locations
Germany
University Hospital Carl Gustav Carus Recruiting
Dresden, Germany, 01307
Contact: Stefan Rasche         Stefan.Rasche@uniklinikum-dresden.de    
Principal Investigator: Stefan Rasche            
Netherlands
Erasmus University Not yet recruiting
Rotterdam, Netherlands
Contact: Sanne Hoeks, MD            
Principal Investigator: Sanne Hoeks            
United Kingdom
University of Leeds, Sectional of Translational Anaesthetic and Surgical Sciences Not yet recruiting
Leeds, United Kingdom, LS9 7TF
Contact: Simon Howell, MD     +44(0)1132065274     s.howell@leeds.ac.uk    
Principal Investigator: Simon Howell, MD            
Sponsors and Collaborators
European Society of Anaesthesiology
University of Leeds
Erasmus Medical Center
Investigators
Study Chair: Simon Howell, MD Sectional of Translational Anaesthetic and Surgical Sciences, University of Leeds, United Kingdom
  More Information

Additional Information:
European Society of Anaesthesiology Website  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: European Society of Anaesthesiology
ClinicalTrials.gov Identifier: NCT01358422     History of Changes
Other Study ID Numbers: OBTAIN
Study First Received: May 20, 2011
Last Updated: February 20, 2012
Health Authority: Belgium: Ethics Committee
United Kingdom: National Health Service

Keywords provided by European Society of Anaesthesiology:
Prospective observational study
major adverse cardiac events (MACE)
clinically significant bleeding events
Dual anti-platelet therapy
aspirin alone therapy
non-cardiac surgery
 percutaneous coronary intervention (PCI)
placement of a bare metal or drug eluting stent
OBTAIN
Simon Howell
ESA

Additional relevant MeSH terms:
Hemorrhage
Thrombosis
Pathologic Processes
 Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013