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

• ClinicalTrials.gov Identifier: NCT01358422
• Recruitment Status: Completed
• First Posted: May 23, 2011
• Last Update Posted: October 14, 2015
• Sponsor: European Society of Anaesthesiology
• Collaborators: University of Leeds; Erasmus Medical Center
• Information provided by (Responsible Party): European Society of Anaesthesiology

Tracking Information

• First Submitted Date: May 20, 2011
• First Posted Date: May 23, 2011
• Last Update Posted Date: October 14, 2015
• Study Start Date: October 2011
• Actual Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 20, 2011)

• 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:

  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 ]
  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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Occurrence of Bleeding and Thrombosis During Antiplatelet Therapy in Non-cardiac Surgery
• Official Title: Occurrence of Bleeding and Thrombosis During Antiplatelet Therapy in Non-cardiac Surgery. A Prospective Observational Study (OBTAIN Study)

Brief Summary

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.

• 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
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• Bleeding
• Thrombosis
• Cardiac Events

• Intervention: Not Provided
• Study Groups/Cohorts: In Patients
• Publications *: 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. No abstract available.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 11, 2014): 830
• Original Estimated Enrollment (submitted: May 20, 2011): 1400
• Actual Study Completion Date: January 2014
• Actual Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

Eligibility 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. -

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany, Netherlands, United Kingdom

Administrative Information

• NCT Number: NCT01358422
• Other Study ID Numbers: OBTAIN
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: European Society of Anaesthesiology
• Original Responsible Party: Michel De Bisschop/European Society of Anaesthesiology Executive Director, European Society of Anaesthesiology, Research Department
• Current Study Sponsor: European Society of Anaesthesiology
• Original Study Sponsor: Same as current

Collaborators

• University of Leeds
• Erasmus Medical Center

Investigators

• Study Chair: Simon Howell, MD; Sectional of Translational Anaesthetic and Surgical Sciences, University of Leeds, United Kingdom

• PRS Account: European Society of Anaesthesiology
• Verification Date: October 2015