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

Bleeding Clinical Trial

— OBTAIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01358422
• Other study ID #: OBTAIN
• Status: Completed
• Phase: N/A
• First received: May 20, 2011
• Last updated: October 12, 2015
• Start date: October 2011
• Est. completion date: January 2014

Study information

• Verified date: October 2015
• Source: European Society of Anaesthesiology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics CommitteeUnited Kingdom: National Health Service
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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. -

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bleeding
• Cardiac Events
• Hemorrhage
• Thrombosis

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
European Society of Anaesthesiology	Erasmus Medical Center, University of Leeds

Countries where clinical trial is conducted

Germany,  Netherlands,  United Kingdom, 

References & 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. — View Citation

Outcome

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

External Links

•   European Society of Anaesthesiology Website