Oxygenator Selection for Cardiopulmonary Bypass
Trial Summary
What is the purpose of this trial?
Open-heart surgery requires temporarily stopping the heart and lungs and diverting the patient's blood to an outside system that takes over the function of the heart and lungs. This is possible through the use of cardiopulmonary bypass (CPB) which diverts blood, through plastic tubing, to a heart-lung machine which includes an oxygenator. The external oxygenator works as an artificial lung. This allows cardiac surgeons to operate in a field that is free of blood, while the patient's body continues to receive healthy blood. CPB is an advanced medical technology that allows for heart surgeries, such as coronary artery bypass, heart valve surgery, and procedures involving major blood vessels. It is recognized that there are many risks associated with its use, including microscopic stress exerted on blood components by the oxygenator and tubing, which can lead to irreversible damage to the blood cells. This effect can contribute to bleeding during and after surgery. This type of bleeding can be difficult to monitor and treat, especially given the limited access to point-of-care blood testing to inform clinicians on what part of the blood is failing to function properly. The investigators will use a point-of-care machine called Plateletworks to test the function of platelets during surgeries which require CPB. Platelets are an important part of blood that help stop bleeding by forming clots. At the investigators' institution two oxygenators are currently used interchangeably. These oxygenators have different properties that may impact how platelets function. This project will help determine if using a higher pressure oxygenator increases the risk of patients bleeding. Additionally, the investigators will compare the platelet data from Plateletworks to data collected from rotational thromboelastometry (ROTEM). This will yield valuable data about commonly used oxygenators and tests which can ultimately improve patient care.
Will I have to stop taking my current medications?
The trial requires that you stop taking direct oral anticoagulants (DOACs) and certain anti-platelet drugs, like ticagrelor and Plavix, at least 72 hours before surgery. However, aspirin (ASA) is allowed. Please consult with your doctor for specific guidance on your medications.
What data supports the effectiveness of the treatment Cardiopulmonary Bypass, LivaNova, Terumo?
Research shows that the LivaNova Inspire6F oxygenator required lower oxygen levels to achieve the same results compared to other models, indicating efficient performance. Additionally, the Terumo FX15 oxygenator demonstrated slightly higher oxygen delivery and content, suggesting effective oxygenation during cardiopulmonary bypass.12345
Is the use of oxygenators in cardiopulmonary bypass generally safe for humans?
Research shows that the safety of oxygenators used in cardiopulmonary bypass can vary between different brands. A study found that the average safety index (a measure of recorded incidents) was 1.6, with some brands having no incidents and others having higher rates. This suggests that while oxygenators are generally safe, their safety can depend on the specific brand used.56789
How does cardiopulmonary bypass differ from other treatments for heart surgery?
Cardiopulmonary bypass is unique because it uses an oxygenator to take over the function of the heart and lungs during surgery, allowing the heart to be stopped while maintaining blood circulation and oxygenation. Membrane oxygenators, which are commonly used, mimic the natural lung's function and cause less blood damage compared to older bubble oxygenators, making them a preferred choice for heart surgeries.810111213
Research Team
Braden Dulong, MD
Principal Investigator
Nova Scotia Health
Eligibility Criteria
Adults scheduled for non-emergency heart surgery with expected long cardiopulmonary bypass times can join. Excluded are those under 18, with bleeding disorders, recent clots or strokes, severe kidney/liver disease, anemia, on certain blood thinners recently (except ASA), pregnant women, and anyone unable to consent.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo cardiopulmonary bypass surgery using either a high pressure or low pressure oxygenator, with platelet function monitored using Plateletworks and ROTEM
Follow-up
Participants are monitored for changes in platelet function and potential bleeding complications post-surgery
Treatment Details
Interventions
- Cardiopulmonary Bypass
- LivaNova
- Terumo
Find a Clinic Near You
Who Is Running the Clinical Trial?
BRADEN DULONG
Lead Sponsor
Braden Dulong
Lead Sponsor