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

NCT01358422 | Completed

• 1 other identifier: OBTAIN
• Study Type: observational
• Target: 830
• Locations: 3 countries
• Sites: 3

Brief Summary

Research questions:

• 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.

Conditions

Bleeding; Thrombosis; Cardiac Events

Keywords

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; European Society of Anaesthesiology

Outcome Measures

Primary Outcomes (2)

• 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: 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.

  In-hospital stay up to 30 days

• 2. Clinically significant bleeding

  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.

  In-hospital stay up to 30 days

Study Arms (1)

In Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• European Society of Anaesthesiology: lead
• University of Leeds: collaborator
• Erasmus Medical Center: collaborator

Study Sites (3)

University Hospital Carl Gustav Carus

Dresden, 01307, Germany

Location

Erasmus University

Rotterdam, Netherlands

Location

University of Leeds, Sectional of Translational Anaesthetic and Surgical Sciences

Leeds, LS9 7TF, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 21544024 BACKGROUND

MeSH Terms

Conditions

Hemorrhage; Thrombosis; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases

Study Officials

• Simon Howell, MD

  Sectional of Translational Anaesthetic and Surgical Sciences, University of Leeds, United Kingdom

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2011
• First Posted: May 23, 2011
• Study Start: October 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: January 1, 2014
• Last Updated: October 14, 2015

Record last verified: 2015-10

Locations

NL (1); GB (1); DE (1)