BleedingOBTAINNCT01358422
Occurrence of Bleeding and Thrombosis During Antiplatelet Therapy in Non-cardiac Surgery
An observational study of Bleeding and Thrombosis, run by European Society of Anaesthesiology at 3 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding, Thrombosis, Cardiac Events
- How many people
- 830 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Oct 2011to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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. -
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United Kingdom1 site
University of Leeds, Sectional of Translational Anaesthetic and Surgical Sciences
Leeds, LS9 7TF
About this study
Official title: Occurrence of Bleeding and Thrombosis During Antiplatelet Therapy in Non-cardiac Surgery. A Prospective Observational Study (OBTAIN Study)
Research questions:
- 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?
Read more
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.
Read the 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.
- 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
- Medical subject headings
- Hemorrhage, Thrombosis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| In Patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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:
- 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.
Measured: In-hospital stay up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 830 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Society of Anaesthesiology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leeds, Erasmus Medical Center
- Responsible party
- Sponsor
- Investigators
- Simon Howell, MD, Study chair, Sectional of Translational Anaesthetic and Surgical Sciences, University of Leeds, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01358422
- Sponsor's protocol ID
- OBTAIN
- Acronym
- OBTAIN
- Status last verified
- Oct 2015
- First submitted
- 20 May 2011
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 21544024
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occurrence of Bleeding and Thrombosis During Antiplatelet Therapy in Non-cardiac Surgery. A Prospective Observational Study (OBTAIN Study)
- ClinicalTrials.gov ID
- NCT01358422
- Acronym / sponsor ID
- OBTAIN / OBTAIN
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 830 participants (actual)
- Lead sponsor
- European Society of AnaesthesiologyUniversity, hospital or other
- Collaborators
- University of Leeds, Erasmus Medical Center
- Study start
- Oct 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 23 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research questions:
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| In Patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
- Background: PubMed 21544024Howell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Howell, MD study chair
Sectional of Translational Anaesthetic and Surgical Sciences, University of Leeds, United Kingdom
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bleeding and Thrombosis, run by European Society of Anaesthesiology at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. MACE (time frame: In-hospital stay up to 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01358422, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.