RecruitingNot ApplicableNCT05588011

Influence of Oxygenator Selection on Platelet Function and Rotational Thromboelastometry Following Cardiopulmonary Bypass


Sponsor

BRADEN DULONG

Enrollment

70 participants

Start Date

Oct 7, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

During open heart surgery, patients are connected to a heart-lung bypass machine. The oxygenator — a key component of that machine — can affect how well blood clots form afterward. This study compares two different oxygenator devices to measure their impact on platelets and clotting ability, which could help surgeons choose devices that lower the risk of post-surgical bleeding. You may be eligible if: - You are 18 or older and weigh at least 60 kg - You are scheduled for non-emergency heart surgery (such as multi-vessel bypass or valve surgery) expected to require a long bypass time You may NOT be eligible if: - You are pregnant - You have a known bleeding disorder - You have significant liver disease or abnormal clotting tests - You have had a blood clot, stroke, or pulmonary embolism in the last 3 months - You are on blood thinners (DOACs) within 72 hours before surgery or antiplatelet drugs (except aspirin) within 3 days of surgery - You have severe anemia (hemoglobin below 110) - You are having emergency surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETerumo

A low pressure oxygenator (Terumo) will be used during cardiopulmonary bypass.

DEVICELivaNova

A high pressure oxygenator (LivaNova) will be used during cardiopulmonary bypass.


Locations(1)

Halifax Infirmary site, Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

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NCT05588011


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